Trial Outcomes & Findings for Subcuticular Suture for Cesarean Skin Incision Closure (NCT NCT02459093)
NCT ID: NCT02459093
Last Updated: 2018-06-01
Results Overview
Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
550 participants
Primary outcome timeframe
30 days
Results posted on
2018-06-01
Participant Flow
Participant milestones
| Measure |
Poliglecaprone 25 Suture
Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery
poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture
|
Polyglactin 910 Suture
Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery
polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture
|
|---|---|---|
|
Overall Study
STARTED
|
275
|
275
|
|
Overall Study
COMPLETED
|
263
|
257
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
Reasons for withdrawal
| Measure |
Poliglecaprone 25 Suture
Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery
poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture
|
Polyglactin 910 Suture
Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery
polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
11
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
Baseline Characteristics
Subcuticular Suture for Cesarean Skin Incision Closure
Baseline characteristics by cohort
| Measure |
Poliglecaprone 25 Suture
n=263 Participants
Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery
poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture
|
Polyglactin 910 Suture
n=257 Participants
Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery
polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture
|
Total
n=520 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
520 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
128 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Cesarean delivery with labor
Scheduled or no labor
|
224 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Cesarean delivery with labor
Any labor
|
39 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Intent to treat analysis
Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)
Outcome measures
| Measure |
Poliglecaprone 25 Suture
n=263 Participants
Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery
poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture
|
Polyglactin 910 Suture
n=257 Participants
Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery
polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture
|
|---|---|---|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Composite wound
|
23 Participants
|
37 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Surgical Site Infection
|
16 Participants
|
25 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Hematoma
|
1 Participants
|
3 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Seroma
|
2 Participants
|
1 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Separation
|
7 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: As treated
Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)
Outcome measures
| Measure |
Poliglecaprone 25 Suture
n=265 Participants
Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery
poliglecaprone 25 suture: cesarean delivery incision closure with poliglecaprone 25 suture
|
Polyglactin 910 Suture
n=217 Participants
Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery
polyglactin 910 suture: cesarean delivery incision closure with polyglactin 910 suture
|
|---|---|---|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Composite wound
|
22 Participants
|
30 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Surgical Site Infection
|
16 Participants
|
20 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Hematoma
|
1 Participants
|
2 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Seroma
|
1 Participants
|
2 Participants
|
|
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)
Separation
|
8 Participants
|
8 Participants
|
Adverse Events
Poliglecaprone 25 Suture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Polyglactin 910 Suture
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