Trial Outcomes & Findings for Retrospective Independent Safety Review of Closed Irrisept Study (NCT NCT05359666)
NCT ID: NCT05359666
Last Updated: 2023-08-14
Results Overview
The primary endpoint was identification of all adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
592 participants
Primary outcome timeframe
up to 30 +/- 3 days
Results posted on
2023-08-14
Participant Flow
CLP-01, a retrospective review study conducted between 03/2020 \& 11/2021, did not enroll new subjects, but relied solely on data collected for the trial IRR-CT-901-2013-01.CLP-01's purpose was to complete the safety endpoint of the closed trial \& ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for \& accurately identified, verified, \& independently adjudicated. CLP-01 did not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01.
CLP-01 included safety data only from trial IRR-CT-901-2013-01. There were 636 ITT subjects (i.e., those who consented into IRR-CT-901-2013-01). There were 592 mITT subjects (i.e., those who consented, randomized to Irrisept or SoC, had a procedure, used irrigation during that procedure \& had verifiable safety data. Of the 592 mITT subjects, 294 subjects were given Irrisept \& 298 subjects were given SOC. The remaining 44 subjects had non-evaluable data \& were not included in the analysis.
Participant milestones
| Measure |
Irrisept
For subjects randomized to the investigational group, Irrisept was used during the surgical procedure, per the provided instructions for use.
Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator.
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Standard of Care (SoC)
For subjects randomized to the control group, any SoC irrigation solution, preferred by the investigator, was used during the surgical procedure.
SoC types were not standardized in IRR-CT-901-2013-01. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloroprep; "Gentamicin \& saline"; unknown; and none.
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|---|---|---|
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Overall Study
STARTED
|
294
|
298
|
|
Overall Study
COMPLETED
|
294
|
298
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Independent Safety Review of Closed Irrisept Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: up to 30 +/- 3 daysThe primary endpoint was identification of all adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Outcome measures
| Measure |
Irrisept
n=294 Participants
Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.
Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use.
|
Standard of Care (SoC)
n=298 Participants
Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.
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|---|---|---|
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All Adverse Events
|
894 Adverse Events
|
962 Adverse Events
|
SECONDARY outcome
Timeframe: up to 30 +/- 3 daysThe secondary endpoint was identification of the number subjects with device-related adverse events from those that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Outcome measures
| Measure |
Irrisept
n=294 Participants
Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.
Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use.
|
Standard of Care (SoC)
n=298 Participants
Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.
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|---|---|---|
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Subjects With Device-Related Adverse Events
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220 Subjects with Device-related AEs
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194 Subjects with Device-related AEs
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SECONDARY outcome
Timeframe: up to 30 +/- 3 daysPopulation: Of the total 1856 adverse events, 894 occurred in subjects on Irrisept and 962 occurred in subjects on SoC. There were 1808 total unrelated AEs (856 for Irrisept \& 952 for SoC), 35 unlikely related AEs (30 for Irrisept \& 5 for SoC), 13 possibly related AEs (8 for Irrisept \& 5 for SoC) and 0 probably \& definitely related AEs (0 for Irrisept \& SoC).
Another secondary endpoint was identification of the overall number device-related adverse events from subjects that participated in the closed study (Protocol #IRR-CT-901-2013-01; NCT #02255487).
Outcome measures
| Measure |
Irrisept
n=894 Adverse Events
Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.
Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use.
|
Standard of Care (SoC)
n=962 Adverse Events
Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.
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|---|---|---|
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Number of Device-Related Adverse Events
Unrelated AEs
|
856 Device-related AEs
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952 Device-related AEs
|
|
Number of Device-Related Adverse Events
Unlikely Related AEs
|
30 Device-related AEs
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5 Device-related AEs
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Number of Device-Related Adverse Events
Possibly Related AEs
|
8 Device-related AEs
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5 Device-related AEs
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|
Number of Device-Related Adverse Events
Probably Related AEs
|
0 Device-related AEs
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0 Device-related AEs
|
|
Number of Device-Related Adverse Events
Definitely Related AEs
|
0 Device-related AEs
|
0 Device-related AEs
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SECONDARY outcome
Timeframe: up to 30 +/- 3 daysPopulation: Device deficiencies were only reported for subjects randomized to Irrisept. Of the 294 subjects randomized to Irrisept, there were 43 device deficiencies. Device deficiencies were "any inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety and/or performance".
For the Irrisept group only, any device deficiencies identified in the medical records and/or source documents (during the closed study when the study device was used, even if the deficiency was not associated with an AE), was recorded.
Outcome measures
| Measure |
Irrisept
n=43 Irrisept Device Deficiencies
Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.
Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use.
|
Standard of Care (SoC)
Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.
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|---|---|---|
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Number of Device Deficiencies
Inadequate identification
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0 Number of Device Deficiencies
|
—
|
|
Number of Device Deficiencies
Quality
|
40 Number of Device Deficiencies
|
—
|
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Number of Device Deficiencies
Reliability
|
0 Number of Device Deficiencies
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—
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Number of Device Deficiencies
Safety
|
0 Number of Device Deficiencies
|
—
|
|
Number of Device Deficiencies
Performance
|
0 Number of Device Deficiencies
|
—
|
|
Number of Device Deficiencies
Malfunction
|
0 Number of Device Deficiencies
|
—
|
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Number of Device Deficiencies
User Error
|
3 Number of Device Deficiencies
|
—
|
Adverse Events
Irrisept
Serious events: 63 serious events
Other events: 157 other events
Deaths: 7 deaths
Standard of Care (SoC)
Serious events: 93 serious events
Other events: 101 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Irrisept
n=294 participants at risk
Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.
Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use.
|
Standard of Care (SoC)
n=298 participants at risk
Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.
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|---|---|---|
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Blood and lymphatic system disorders
Blood/Lymphatic SAEs
|
0.68%
2/294 • Number of events 2 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
1.0%
3/298 • Number of events 3 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Cardiac disorders
Cardiac SAEs
|
1.7%
5/294 • Number of events 6 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
4.4%
13/298 • Number of events 15 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Gastrointestinal disorders
GI SAEs
|
5.8%
17/294 • Number of events 20 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
5.0%
15/298 • Number of events 16 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
General disorders
General SAEs
|
0.68%
2/294 • Number of events 2 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
1.3%
4/298 • Number of events 4 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Hepatobiliary disorders
Hepatobiliary SAEs
|
0.34%
1/294 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
1.0%
3/298 • Number of events 3 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Infections and infestations
Infection SAEs
|
10.9%
32/294 • Number of events 37 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
9.7%
29/298 • Number of events 29 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Injury, poisoning and procedural complications
Injury SAEs
|
6.5%
19/294 • Number of events 22 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
6.4%
19/298 • Number of events 20 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Metabolism and nutrition disorders
Metabolic SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.67%
2/298 • Number of events 2 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Nervous system disorders
Nervous System SAEs
|
1.7%
5/294 • Number of events 9 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.34%
1/298 • Number of events 2 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Psychiatric disorders
Psychiatric SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.67%
2/298 • Number of events 2 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Renal and urinary disorders
Renal/Urinary SAEs
|
1.0%
3/294 • Number of events 3 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
1.0%
3/298 • Number of events 3 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory SAEs
|
4.4%
13/294 • Number of events 15 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
5.4%
16/298 • Number of events 18 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Vascular disorders
Vascular SAEs
|
2.4%
7/294 • Number of events 7 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
2.0%
6/298 • Number of events 6 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Ear and labyrinth disorders
Ear/Labyrinth SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Endocrine disorders
Endocrine SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Eye disorders
Ocular SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Immune system disorders
Immune System SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Investigations
Investigational SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Reproductive system and breast disorders
Reproductive System SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Skin and subcutaneous tissue disorders
Skin/Subcutaneous Tissue SAEs
|
0.00%
0/294 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
Other adverse events
| Measure |
Irrisept
n=294 participants at risk
Irrisept® was used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Irrisept: Irrisept® is a manual, self-contained irrigation device designed for wound cleansing and irrigation. The solution is 0.05% Chlorhexidine Gluconate (CHG) in sterile water for irrigation, USP (99.95%). Irrisept contents include the solution, a 450 mL bottle, and the Irriprobe applicator. Irrisept is a manual, self-contained irrigation device that can produce 7-8 psi of pressure for effective wound cleansing and irrigation. The user squeezes the bottle to create streams of solution and directs the fluid from the applicator onto a wound. The mechanical action of the streams of fluid being applied over a wound removes particulates and debris.
Subjects randomized to Irrisept on study protocol IRR-CT-901-2013-01 used the device, per the provided Instructions for Use.
|
Standard of Care (SoC)
n=298 participants at risk
Institution determined the type of SoC used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen for study protocol IRR-CT-901-2013-01.
Standard of Care: Subjects randomized to SoC on study protocol IRR-CT-901-2013-01 used any SoC type, per the investigator's discretion. SoC types were not standardized. Sites recorded SoC information as free text. The following were recorded as SoC types: Saline (recorded as "normal", "warm" and/or "sterile" saline or saline solution); Sodium Chloride (recorded as "sodium chloride (NACL)" or "NACL 0.9%"); "SoC"; Irrisept (recorded as "normal saline \& Irrisept" and "Irrisept"); Chloraprep; "Gentamicin \& saline"; unknown; and none.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Lymphatic AEs
|
19.7%
58/294 • Number of events 101 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
20.1%
60/298 • Number of events 109 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Cardiac disorders
Cardiac AEs
|
16.3%
48/294 • Number of events 54 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
11.7%
35/298 • Number of events 37 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Ear and labyrinth disorders
Ear/Labyrinth AEs
|
0.34%
1/294 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Endocrine disorders
Endocrine AEs
|
1.0%
3/294 • Number of events 3 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Eye disorders
Ocular AEs
|
0.34%
1/294 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Gastrointestinal disorders
GI AEs
|
23.8%
70/294 • Number of events 98 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
24.8%
74/298 • Number of events 111 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
General disorders
General AEs
|
13.3%
39/294 • Number of events 39 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
12.1%
36/298 • Number of events 37 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Hepatobiliary disorders
Hepatobiliary AEs
|
0.34%
1/294 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
1.3%
4/298 • Number of events 4 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Infections and infestations
Infection AEs
|
20.4%
60/294 • Number of events 67 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
17.4%
52/298 • Number of events 72 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Injury, poisoning and procedural complications
Injury AEs
|
17.3%
51/294 • Number of events 52 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
16.1%
48/298 • Number of events 50 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Investigations
Investigational AEs
|
1.7%
5/294 • Number of events 9 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
4.0%
12/298 • Number of events 15 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Metabolism and nutrition disorders
Metabolic AEs
|
21.1%
62/294 • Number of events 165 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
20.5%
61/298 • Number of events 192 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal AEs
|
1.0%
3/294 • Number of events 4 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
2.0%
6/298 • Number of events 6 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm AEs
|
0.34%
1/294 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
1.0%
3/298 • Number of events 3 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Nervous system disorders
Nervous System AEs
|
3.1%
9/294 • Number of events 9 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
2.7%
8/298 • Number of events 10 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Psychiatric disorders
Psychiatric AEs
|
4.8%
14/294 • Number of events 17 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
5.7%
17/298 • Number of events 23 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Renal and urinary disorders
Renal/Urinary AEs
|
11.2%
33/294 • Number of events 34 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
10.1%
30/298 • Number of events 33 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Reproductive system and breast disorders
Reproductive System AEs
|
1.4%
4/294 • Number of events 4 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.34%
1/298 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory AEs
|
16.0%
47/294 • Number of events 63 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
18.5%
55/298 • Number of events 76 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Skin and subcutaneous tissue disorders
Skin/Subcutaneous Tissue AEs
|
4.1%
12/294 • Number of events 12 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
5.4%
16/298 • Number of events 16 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Vascular disorders
Vascular AEs
|
9.9%
29/294 • Number of events 34 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
11.7%
35/298 • Number of events 44 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
|
Skin and subcutaneous tissue disorders
Adverse Device Effects
|
0.34%
1/294 • Number of events 1 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
0.00%
0/298 • CLP-01 was a retrospective review study & did not enroll new subjects. AEs for subjects who participated in IRR-CT-901-2013-01 were reviewed beginning at informed consent completion, up to study completion (30 +/-3 days post-surgical procedure) or until AE resolution. CLP-01 relied solely on data collected in the subject source & medical records for the closed study in IRR-CT-901-2013-01. The study IRR-CT-901-2013-01 was conducted between 2015 and 2017.
The following were collected: 1) # of SAEs, 2) all-cause mortality rates/randomization group \& 3) categories of organ classes for all AEs \& SAEs. No SADEs or USADEs were identified in CLP-01 for Irrisept or SoC. There was 1 ADE for 1 Irrisept subject; there were 0 SoC ADEs. All other AEs, anticipated or unanticipated, totaled 894 for Irrisept \& 962 for SoC. There were 220 \& 194 Irrisept \& SoC subjects, respectively, that had AEs/SAEs/ADEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place