Trial Outcomes & Findings for The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study) (NCT NCT04957732)
NCT ID: NCT04957732
Last Updated: 2022-02-02
Results Overview
Oral antibiotic use was used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
24, 48, 72 & 96-hour visit intervals
Results posted on
2022-02-02
Participant Flow
From January 2010 to November 2011, patients with skin and soft tissue infections, in the form of abscesses, were recruited from Shands Emergency Department at the University of Florida.
The planned sample size was 107 subjects enrolled in each arm. However, during the study, the site rearranged their ED and no longer treated abscesses. As a result, the study was terminated early after enrolling 35 subjects. Of those, 19 were on SoC and 16 were on Irrisept. A total of 30 subjects completed the study, with 12 subjects on Irrisept and 18 on SoC. For the 5 subjects that did not complete the study, 4 were on Irrisept and 1 on SoC.
Participant milestones
| Measure |
Standard of Care (SoC)
For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.
SoC consisted of irrigation with normal saline, using the same proprietary abscess irrigation tip as the Irrisept arm. SoC was used at the initial visit and at each subsequent 48-hour visit interval until abscess healing.
|
Irrisept
For subjects randomized to the investigational group, Irrisept was used.
Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The device has an option for use with an Irriprobe applicator or an abscess irrigation tip. Irrisept was used at the initial visit and at each subsequent 48-hour visit interval until abscess healing.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to the control group, Standard of Care (SoC) (normal saline) was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age - Known · <=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Age - Known · Between 18 and 65 years
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
Age - Known · >=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
12 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24, 48, 72 & 96-hour visit intervalsPopulation: There were 4 timepoints for assessing abscess wound healing with the use of oral antibiotics: 24, 48, 72 \& 96 hours.
Oral antibiotic use was used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline).
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Number of Subjects That Used Oral Antibiotics
Number of Subjects Requiring Oral Antibiotics at 24-hour Follow-up
|
1 participants
|
0 participants
|
|
Number of Subjects That Used Oral Antibiotics
Number of Subjects Requiring Oral Antibiotics at 48-hour Follow-up
|
2 participants
|
1 participants
|
|
Number of Subjects That Used Oral Antibiotics
Number of Subjects Requiring Oral Antibiotics at Follow-up : 72-hour Follow-up
|
1 participants
|
0 participants
|
|
Number of Subjects That Used Oral Antibiotics
Number of Subjects Requiring Oral Antibiotics at Follow-up : 96-hour Follow-up
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.Population: 5 scale units were analyzed. These include: 1 = clinically resolved, no signs of active infection; 2 = markedly improved, resolving infection and healing; 3 = improved with some remaining signs of active infection; 4 = unchanged, stable without signs of worsening clinical infection and; 5 = worsening conditions.
Wound improvement assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Wound improvement was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = clinically resolved, no signs of active infection; 2 = markedly improved, resolving infection and healing; 3 = improved with some remaining signs of active infection; 4 = unchanged, stable without signs of worsening clinical infection and; 5 = worsening conditions. The results are shown using a chi-squared test, as an average Likert score compared between the 2 arms.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Abscess Wound Healing Determined By Wound Improvement Score
|
2.88 score on a scale
Standard Deviation 0.93
|
2.50 score on a scale
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.Population: 5 scale units were analyzed. These include: 1 = none; 2 = scant; 3 = minimal; 4 = moderate and; 5 = copious.
Exudation assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Exudation was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = none; 2 = scant; 3 = minimal; 4 = moderate and; 5 = copious. The results are shown using a chi-squared test to compare the means at baseline and 48-hours. A two-tailed t-test was conducted for the mean improvement.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Abscess Wound Healing Determined By Exudation Score
Baseline
|
2.31 score on a scale
Standard Deviation 1.21
|
2.40 score on a scale
Standard Deviation 1.43
|
|
Abscess Wound Healing Determined By Exudation Score
48-Hour Follow-up Visit
|
2.00 score on a scale
Standard Deviation 1.00
|
2.10 score on a scale
Standard Deviation 1.44
|
PRIMARY outcome
Timeframe: Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.Pain assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Pain was assessed using a Visual Analogue Scale (VAS). The scale was measured in centimeters (cm) which ranged between 0 cm ("no pain" at the far left) to 9.5 cm ("most severe pain" at the far right). Subjects marked their pain rating on the scale with an "X". The distance from the beginning of the scale (far left) to the "X" was measured in cm. The mean VAS score was assessed at baseline and at the 48-hour follow-up visit. The overall mean improvement was compared between the 2 arms using two-tailed t-tests.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Abscess Wound Healing Determined By Pain Score
Baseline
|
5.27 units on a scale
Standard Deviation 2.79
|
6.33 units on a scale
Standard Deviation 2.42
|
|
Abscess Wound Healing Determined By Pain Score
48-Hour Follow-up
|
3.80 units on a scale
Standard Deviation 3.08
|
3.91 units on a scale
Standard Deviation 3.30
|
SECONDARY outcome
Timeframe: The need for oral antibiotics, assessed by erythema, was reviewed at baseline and the 48-hour visit.Erythema was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. The mean circumference of the erythema area, measured in centimeters (cm), was assessed at baseline and 48-hours later. This was performed by the clinician drawing a circle with a marker around the area of redness surrounding the abscess. Mean improvement was compared between the 2 arms using two-tailed t-tests.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Oral Antibiotic Use Required, Determined By Erythema Area Size
Baseline
|
4.01 centimeters (cm)
Standard Deviation 2.44
|
3.25 centimeters (cm)
Standard Deviation 2.34
|
|
Oral Antibiotic Use Required, Determined By Erythema Area Size
48-hour Follow-up
|
3.41 centimeters (cm)
Standard Deviation 4.85
|
1.70 centimeters (cm)
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 48-hours after baselinePopulation: Induration was assessed at baseline and the 48-hour follow-up visit. The length and width (in centimeters) of the abscess was used to measure the wound area (induration). For each subject, the difference in area between the two timepoints was used to find the mean improvement for both arms.
Induration or abscess size was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. The need for oral antibiotics, assessed by the mean induration or abscess size (measured in cm), was reviewed at baseline and the 48-hour visit. Mean improvement was compared between the 2 arms using two-tailed t-tests.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)
Baseline
|
12.263 centimeters (cm)
Standard Deviation 10.03
|
10.238 centimeters (cm)
Standard Deviation 8.00
|
|
Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)
48-Hour Follow-up
|
8.843 centimeters (cm)
Standard Deviation 8.53
|
5.875 centimeters (cm)
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.Population: Warmth was assessed at baseline and the 48-hour follow-up visit. Chi-square tests for answers "yes" or "no" were run at the baseline and 48-hour follow-up visits.
Warmth was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. Clinicians recorded whether the abscess was warm for each subject initially and after 48 hours.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Oral Antibiotic Use Required Due To Warmth
Baseline · Yes
|
14 Participants
|
8 Participants
|
|
Oral Antibiotic Use Required Due To Warmth
Baseline · No
|
4 Participants
|
4 Participants
|
|
Oral Antibiotic Use Required Due To Warmth
48-Hour Follow-up · Yes
|
9 Participants
|
4 Participants
|
|
Oral Antibiotic Use Required Due To Warmth
48-Hour Follow-up · No
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.Population: Fluctuance was assessed at baseline and the 48-hour follow-up visit. Chi-square tests for answers "yes" or "no" were run at the baseline and 48-hour follow-up visits.
The presence of fluctuance was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. Clinicians recorded whether fluctuance was present for each subject initially and after 48 hours.
Outcome measures
| Measure |
Standard of Care (SoC)
n=18 Participants
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=12 Participants
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Oral Antibiotic Use Required Due To Fluctuance
48-hour Follow-up · No
|
14 Participants
|
10 Participants
|
|
Oral Antibiotic Use Required Due To Fluctuance
Baseline · Yes
|
8 Participants
|
5 Participants
|
|
Oral Antibiotic Use Required Due To Fluctuance
Baseline · No
|
10 Participants
|
7 Participants
|
|
Oral Antibiotic Use Required Due To Fluctuance
48-hour Follow-up · Yes
|
4 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 daysPopulation: 0
The tertiary objective was to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing in patients that have MRSA-positive wounds compared to pressurized irrigation with normal saline. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed. To be compliant with the CT.gov template, although the information is incorrect and no data was captured this outcome, data was entered for Irrisept subjects.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Baseline and up to 48-hours laterPopulation: There was a total of 42 AEs for which causality assessments were made; 28 AEs were from subjects on SoC and 14 were from subjects on Irrisept.
Causality for each worsening event was determined by using the following categories: 'related', 'possibly related', 'unlikely related', 'unrelated' or 'unknown'.
Outcome measures
| Measure |
Standard of Care (SoC)
n=28 Total Number of Worsening Symptoms
For subjects randomized to SoC, normal saline was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
Irrisept
n=14 Total Number of Worsening Symptoms
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made at the initial visit and at each subsequent 24-hour visit interval (up to 96 hours) until abscess healing.
|
|---|---|---|
|
Worsening Symptoms Causality
Related Worsening Symptom
|
0 Total Number of Worsening Symptoms
|
0 Total Number of Worsening Symptoms
|
|
Worsening Symptoms Causality
Possibly Related Worsening Symptom
|
10 Total Number of Worsening Symptoms
|
2 Total Number of Worsening Symptoms
|
|
Worsening Symptoms Causality
Unlikely Related Worsening Symptom
|
14 Total Number of Worsening Symptoms
|
7 Total Number of Worsening Symptoms
|
|
Worsening Symptoms Causality
Unrelated Worsening Symptom
|
3 Total Number of Worsening Symptoms
|
5 Total Number of Worsening Symptoms
|
|
Worsening Symptoms Causality
Unknown Relation Worsening Symptom
|
1 Total Number of Worsening Symptoms
|
0 Total Number of Worsening Symptoms
|
Adverse Events
Standard of Care (SoC)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Irrisept
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care (SoC)
n=18 participants at risk
For subjects randomized to SoC, normal saline was used.
Assessments were made anytime after consent, while the study participated in the trial.
|
Irrisept
n=12 participants at risk
For subjects randomized to the investigational group, Irrisept was used.
Assessments were made anytime after consent, while the study participated in the trial.
|
|---|---|---|
|
Infections and infestations
All Worsening Symptoms
|
66.7%
12/18 • Number of events 28 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
50.0%
6/12 • Number of events 14 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Pain
|
22.2%
4/18 • Number of events 4 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
0.00%
0/12 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Vomiting
|
5.6%
1/18 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
0.00%
0/12 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Erythema
|
27.8%
5/18 • Number of events 5 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
8.3%
1/12 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Swelling
|
11.1%
2/18 • Number of events 2 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
25.0%
3/12 • Number of events 3 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Exudation
|
22.2%
4/18 • Number of events 4 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
16.7%
2/12 • Number of events 2 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Depth
|
5.6%
1/18 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
33.3%
4/12 • Number of events 4 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Induration
|
33.3%
6/18 • Number of events 6 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
8.3%
1/12 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Fluctuance
|
5.6%
1/18 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
0.00%
0/12 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Active Infection
|
5.6%
1/18 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
25.0%
3/12 • Number of events 3 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Warmth
|
11.1%
2/18 • Number of events 2 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
0.00%
0/12 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
|
Infections and infestations
Redness
|
5.6%
1/18 • Number of events 1 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
0.00%
0/12 • Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
|
Additional Information
Richard Petrik, MD, Clinical Assistant Professor
University of Florida Shands Emergency Department
Phone: 352-265-5911
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place