Trial Outcomes & Findings for Tissue Adhesive vs. Sterile Strips After Cesarean Delivery (NCT NCT02838017)
NCT ID: NCT02838017
Last Updated: 2019-08-14
Results Overview
Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
504 participants
Primary outcome timeframe
6-8 weeks from cesarean delivery
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Tissue Adhesive
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Overall Study
STARTED
|
252
|
252
|
|
Overall Study
COMPLETED
|
238
|
241
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
Tissue Adhesive
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
11
|
Baseline Characteristics
Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Tissue Adhesive
n=252 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Steri-Strips
n=252 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
33.5 years
n=7 Participants
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
504 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
191 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
121 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
74 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Nulliparity
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Prior cesarean delivery
|
144 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Body mass index at delivery
|
32.9 kg/m^2
n=5 Participants
|
33.5 kg/m^2
n=7 Participants
|
33.3 kg/m^2
n=5 Participants
|
|
Diabetes mellitus
|
30 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Hypertensive disorders
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Tobacco use
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Immunocompromised
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cesarean delivery while in labor
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Chorioamnionitis
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Blood loss
|
700.0 mL
n=5 Participants
|
745.0 mL
n=7 Participants
|
700.0 mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-8 weeks from cesarean deliveryWound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
Outcome measures
| Measure |
Tissue Adhesive
n=238 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
n=241 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Number of Participants With Wound Complication
|
18 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Within 8 weeks from cesarean deliveryOutcome measures
| Measure |
Tissue Adhesive
n=238 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
n=241 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Number of Participants With Readmission for Wound Complication
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6-8 weeks from cesarean deliveryPopulation: Completion of the modified Patient Scar Assessment Scale was accomplished in 203/252 (80.6%) of women in the tissue adhesive group and 203/252 (80.6%) of women in the sterile strips group.
The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups. Please see website in links section for more details on this assessment tool.
Outcome measures
| Measure |
Tissue Adhesive
n=203 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
n=203 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Satisfaction With Cesarean Scar
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Within 8 weeks of deliveryThe investigators will review medical records to assess for ambulatory visits for wound complaints
Outcome measures
| Measure |
Tissue Adhesive
n=238 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
n=241 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: At time of deliveryThe investigators will review operative records to assess operative time
Outcome measures
| Measure |
Tissue Adhesive
n=238 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
n=241 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Operative Time
|
58.5 min
Interval 48.0 to 70.3
|
60 min
Interval 51.0 to 72.0
|
SECONDARY outcome
Timeframe: Within 8 weeks of deliveryThe investigators will review medical records to assess for antibiotic prescriptions for wound complications
Outcome measures
| Measure |
Tissue Adhesive
n=238 Participants
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
|
Sterile Strips
n=241 Participants
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
|
|---|---|---|
|
Number of Participants Requiring Antibiotic Treatment for Wound Complication
|
7 Participants
|
12 Participants
|
Adverse Events
Tissue Adhesive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sterile Strips
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place