Trial Outcomes & Findings for Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery. (NCT NCT02731573)
NCT ID: NCT02731573
Last Updated: 2026-04-13
Results Overview
The primary endpoint was the decrease in infection rate as measured by the proportion of subjects with at least one identified sternal infection, DSWI (Deep sternal wound infections) and SSWI (Superficial Sternal Wound Infection) within 90 days of post-cardiac surgery. One patient in the Control arm had an SSWI on day 6 post-surgery. The infection was confirmed by a bacteriology test positive for Proteus mirabilis. No subjects in the D-PLEX treatment arm experienced any sternal wound infections and no infection was confirmed during 90 days post-surgery.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Within 90 days post-cardiac surgery.
Results posted on
2026-04-13
Participant Flow
Subjects who met the eligibility criteria and provided signed informed consent were enrolled in the study. In Part 1 of the study, subjects were treated with D-PLEX concomitantly with SOC (Standard of Care). In Part 2 of the study the subjects were randomized 2:1 to receive D-PLEX concomitantly with SOC or SOC only.
A total of 81 subjects were enrolled in the study as follows: Part 1 Open Label, Single Arm: Twenty (20) subjects were enrolled in Part 1 of the study and treated with D-PLEX concomitantly with SOC (Standard of Care). Part 2 Randomized, Single-blinded: Sixty-one (61) subjects were enrolled in Part 2 of the study and randomized to the D-PLEX + SOC (Standard of Care) treatment arm (40 subjects) or to the SOC (Standard of Care) arm (21 subjects).
Participant milestones
| Measure |
D-PLEX + SoC
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
D-PLEX: D-PLEX will be administered as a single application during the open-heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
Standard of Care (SoC)
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open-heart surgery according to standard of care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
21
|
|
Overall Study
COMPLETED
|
50
|
19
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
Baseline characteristics by cohort
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
D-PLEX: D-PLEX will be administered as a single application during the open-heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open-heart surgery according to standard of care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 11.3 • n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
65.6 years
STANDARD_DEVIATION 11 • n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
63.5 years
STANDARD_DEVIATION 11.1 • n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Sex: Female, Male
Female
|
14 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
5 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
19 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Sex: Female, Male
Male
|
46 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
16 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
62 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
2 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
White
|
57 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
21 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
78 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
0 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
1 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
Region of Enrollment
Israel
|
60 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
21 Participants
n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
81 Participants
n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
|
BMI
|
27 kg/m^2
STANDARD_DEVIATION 3.7 • n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
31.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=193 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
29.4 kg/m^2
STANDARD_DEVIATION 4.1 • n=386 Participants • Two-part study; Part 1 Open Label, Single arm \& Part 2 Randomized, Single-blinded, D-PLEX Concomitantly with Standard Of Care vs. Standard of Care alone.
|
PRIMARY outcome
Timeframe: Within 90 days post-cardiac surgery.The primary endpoint was the decrease in infection rate as measured by the proportion of subjects with at least one identified sternal infection, DSWI (Deep sternal wound infections) and SSWI (Superficial Sternal Wound Infection) within 90 days of post-cardiac surgery. One patient in the Control arm had an SSWI on day 6 post-surgery. The infection was confirmed by a bacteriology test positive for Proteus mirabilis. No subjects in the D-PLEX treatment arm experienced any sternal wound infections and no infection was confirmed during 90 days post-surgery.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery.
|
0 Percentage of participants
|
4.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Within 90 days post-cardiac surgery.No readmissions due to sternal surgical site infections were reported in any treatment arm.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Decrease in the Number of Readmissions Due to Sternal Surgical Site Infection
|
0 Readmissions
|
0 Readmissions
|
SECONDARY outcome
Timeframe: Within 90 days post-cardiac surgery.No surgical re-interventions due to sternal surgical site infections were required in any treatment arm.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Decrease in Number of Surgical Re-interventions Due to Sternal Surgical Site Infection.
|
0 Re-interventions
|
0 Re-interventions
|
SECONDARY outcome
Timeframe: Within 90 days post-cardiac surgery.Population: One event to one subject within 6 days in the Control arm.
Only one subject in the Control arm group had an sternal infection on day 6 post cardiac surgery.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Time to Sternal Infection Post-cardiac Surgery.
|
0 days
Interval 0.0 to 0.0
|
6 days
Interval 6.0 to 6.0
|
SECONDARY outcome
Timeframe: Within 30 days post operation.One subject in the Control arm group had a Sternal Infection during the first 30 days after surgery. None of the subjects in the D-PLEX+SOC (Treatment arm) group had any sternal infection during this period.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Decrease of Sternal Infection Rate, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) During the First 30 Days Post Operation.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Between day 30 and 3 months.No sternal surgical site infections were reported in any treatment arm between Day 30 and 90 days after the surgery.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Decrease in the Total Number of Sternal Infections, DSWI (Deep Sternal Wound Infections) and SSWI (Superficial Sternal Wound Infection) Between Day 30 and 3 Months.
|
0 number of SSI
|
0 number of SSI
|
SECONDARY outcome
Timeframe: Within 90 days post-cardiac surgery.No hospitalizations due to sternal surgical site infections were reported during the study.
Outcome measures
| Measure |
D-PLEX + SoC
n=60 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
|
Standard of Care (SoC)
n=21 Participants
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Decrease in the Number of Hospitalization Days Due to Sternal Surgical Site Infection.
|
0 days
|
0 days
|
Adverse Events
D-PLEX + SoC
Serious events: 22 serious events
Other events: 48 other events
Deaths: 1 deaths
Standard of Care (SoC)
Serious events: 12 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D-PLEX + SoC
n=60 participants at risk
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
D-PLEX: D-PLEX will be administered as a single application during the open-heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
Standard of Care (SoC)
n=21 participants at risk
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open-heart surgery according to standard of care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Angina pectoris
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
3.3%
2/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Sinus arrhythmia
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Chest pain
|
3.3%
2/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Device related infection
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Diabetic foot infection
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Endocarditis
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Postoperative wound infection
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Viral infection
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
5.0%
3/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Nervous system disorders
Lumbosacral plexopathy
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
Ischaemic limb pain
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
Other adverse events
| Measure |
D-PLEX + SoC
n=60 participants at risk
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open heart surgery according to standard of care with treatment by D-PLEX.
D-PLEX: D-PLEX will be administered as a single application during the open-heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
Standard of Care (SoC)
n=21 participants at risk
Subjects who meet the eligibility criteria and provide signed informed consent, will undergo open-heart surgery according to standard of care.
Open heart surgery: Subject will undergo open heart surgery according to standard of care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
8/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
30.0%
18/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
23.8%
5/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Bradycardia
|
5.0%
3/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Chest pain
|
5.0%
3/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Oedema peripheral
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
General disorders
Pyrexia
|
1.7%
1/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Pneumonia
|
5.0%
3/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Postoperative wound infection
|
10.0%
6/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
5.0%
3/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
18.3%
11/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
23.8%
5/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
5.0%
3/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
4.8%
1/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
10.0%
6/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
14.3%
3/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Post pericardiotomy syndrome
|
13.3%
8/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
6/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
12/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
38.1%
8/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.7%
4/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
0.00%
0/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
|
Vascular disorders
Hemodynamic instability
|
3.3%
2/60 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
9.5%
2/21 • 6 months
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place