Trial Outcomes & Findings for A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study (NCT NCT05903547)
NCT ID: NCT05903547
Last Updated: 2026-04-07
Results Overview
The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
Assessed at 6-weeks postpartum
Results posted on
2026-04-07
Participant Flow
Participant milestones
| Measure |
Dermabond Prineo Group
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
78
|
|
Overall Study
COMPLETED
|
73
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study
Baseline characteristics by cohort
| Measure |
Dermabond Prineo Group
n=73 Participants
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 Participants
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 5.3 • n=527 Participants
|
33.1 years
STANDARD_DEVIATION 5.6 • n=527 Participants
|
34 years
STANDARD_DEVIATION 5.5 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=527 Participants
|
78 Participants
n=527 Participants
|
151 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=527 Participants
|
42 Participants
n=527 Participants
|
83 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=527 Participants
|
33 Participants
n=527 Participants
|
60 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=527 Participants
|
3 Participants
n=527 Participants
|
8 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
4 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=527 Participants
|
17 Participants
n=527 Participants
|
29 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=527 Participants
|
25 Participants
n=527 Participants
|
50 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=527 Participants
|
35 Participants
n=527 Participants
|
68 Participants
n=1054 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=527 Participants
|
78 participants
n=527 Participants
|
151 participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6-weeks postpartumThe patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.
Outcome measures
| Measure |
Dermabond Prineo Group
n=73 Participants
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 Participants
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Patient Scar Satisfaction Scale Score
|
13 score on a scale
Interval 9.0 to 20.0
|
13.5 score on a scale
Interval 9.0 to 21.8
|
SECONDARY outcome
Timeframe: Assessed during delivery hospitalization and at 6-week follow-upA composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence.
Outcome measures
| Measure |
Dermabond Prineo Group
n=73 Participants
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 Participants
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Incidence of Surgical Site Infection (SSI)
at time of delivery
|
2 surgical site infections
|
2 surgical site infections
|
|
Incidence of Surgical Site Infection (SSI)
6-week follow-up
|
7 surgical site infections
|
6 surgical site infections
|
SECONDARY outcome
Timeframe: IntraoperativeThe skin closure time will be assessed.
Outcome measures
| Measure |
Dermabond Prineo Group
n=73 Participants
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 Participants
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Skin Closure Time
|
8.0 minutes
Interval 6.0 to 11.0
|
9.0 minutes
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: IntraoperativeThe total operative time will be assessed.
Outcome measures
| Measure |
Dermabond Prineo Group
n=73 Participants
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 Participants
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Operative Time
|
65.5 minutes
Interval 56.8 to 82.2
|
64.5 minutes
Interval 50.0 to 81.0
|
Adverse Events
Dermabond Prineo Group
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Suture Group
Serious events: 11 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dermabond Prineo Group
n=73 participants at risk
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 participants at risk
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Prolonged Hospitalization
|
0.00%
0/73 • Up to 6 weeks post-surgery
|
2.6%
2/78 • Up to 6 weeks post-surgery
|
|
Pregnancy, puerperium and perinatal conditions
Readmission or presentation to ED
|
6.8%
5/73 • Up to 6 weeks post-surgery
|
11.5%
9/78 • Up to 6 weeks post-surgery
|
Other adverse events
| Measure |
Dermabond Prineo Group
n=73 participants at risk
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo: For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
|
Suture Group
n=78 participants at risk
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture: For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
|
|---|---|---|
|
Surgical and medical procedures
Surgical site complication
|
12.3%
9/73 • Up to 6 weeks post-surgery
|
10.3%
8/78 • Up to 6 weeks post-surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place