Trial Outcomes & Findings for Cesarean Trial of Staples vs. Sutures (NCT NCT01211600)
NCT ID: NCT01211600
Last Updated: 2019-11-26
Results Overview
The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.
COMPLETED
NA
746 participants
Within 6 weeks of postpartum
2019-11-26
Participant Flow
Participant milestones
| Measure |
Suture
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
Interrupted Ethicon Staples
|
|---|---|---|
|
Overall Study
STARTED
|
370
|
376
|
|
Overall Study
COMPLETED
|
370
|
376
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cesarean Trial of Staples vs. Sutures
Baseline characteristics by cohort
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
Total
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.0 years
n=99 Participants
|
31.0 years
n=107 Participants
|
31.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
370 Participants
n=99 Participants
|
376 Participants
n=107 Participants
|
746 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
158 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
325 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
162 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Pregnancy History - Singleton Gestation
|
353 Participants
n=99 Participants
|
351 Participants
n=107 Participants
|
704 Participants
n=206 Participants
|
|
Number of Previous Cesareans
0 Previous Cesareans
|
180 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
357 Participants
n=206 Participants
|
|
Number of Previous Cesareans
1 Previous Cesarean
|
120 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Number of Previous Cesareans
More than 1 Previous Cesarean
|
70 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Term Gestation
|
317 Participants
n=99 Participants
|
329 Participants
n=107 Participants
|
646 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 6 weeks of postpartumThe primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Number of Participants With Wound Complications
Total patients with at least 1 wound complicatin
|
18 Participants
|
40 Participants
|
|
Number of Participants With Wound Complications
Infection
|
9 Participants
|
14 Participants
|
|
Number of Participants With Wound Complications
Hematoma
|
2 Participants
|
4 Participants
|
|
Number of Participants With Wound Complications
Seroma
|
5 Participants
|
6 Participants
|
|
Number of Participants With Wound Complications
Separation
|
6 Participants
|
28 Participants
|
|
Number of Participants With Wound Complications
Readmission for wound complication
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior.
Outcome measures
| Measure |
Suture
n=286 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=291 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Patient Scar Assessment Scale Scores for Evaluation of Cosmesis
|
15 score on a scale
Interval 10.0 to 25.0
|
20 score on a scale
Interval 11.0 to 28.0
|
SECONDARY outcome
Timeframe: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.Population: Patient satisfaction data were available for 606 participants. Two participants in the Staples arm did not provide scores for scar appearance satisfaction. This is why we are representing 305 of the 307 subjects' responses to satisfaction of scar appearance.
Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.
Outcome measures
| Measure |
Suture
n=307 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=299 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Patient Satisfaction With Closure Method and Scar Appearance
Satisfaction with Closure Method
|
9 score on a scale
Interval 6.0 to 10.0
|
10 score on a scale
Interval 9.0 to 10.0
|
|
Patient Satisfaction With Closure Method and Scar Appearance
Satisfaction with Scar Appearance
|
9 score on a scale
Interval 7.0 to 10.0
|
9 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Immediately postpartum to time of discharge, which is typically 3-4 days post-cesareanWhether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Pain Perception
Less than 24 hours
|
3.5 score on a scale
Interval 2.0 to 5.0
|
3.6 score on a scale
Interval 2.2 to 5.0
|
|
Pain Perception
24 - 47 hours
|
4.3 score on a scale
Interval 3.5 to 5.2
|
4.3 score on a scale
Interval 3.4 to 5.2
|
|
Pain Perception
48 - 72 hours
|
4.3 score on a scale
Interval 3.5 to 5.3
|
4.2 score on a scale
Interval 3.3 to 5.1
|
|
Pain Perception
Pain at time of Discharge
|
3.5 score on a scale
Interval 2.0 to 5.0
|
3.6 score on a scale
Interval 2.2 to 5.0
|
SECONDARY outcome
Timeframe: Within 6 weeks postpartumPopulation: The number analyzed in the "Number of visits - diagnosed wound complication" and "Number of visits - no diagnosed wound complication" rows indicates the breakdown of subjects within each arm that did and did not have a diagnosed wound complication.
Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Additional Provider Visits
All wound visits
|
.9 Number of Visits per participant
Interval 0.0 to 7.0
|
1.5 Number of Visits per participant
Interval 0.0 to 7.0
|
|
Additional Provider Visits
Number of visits - diagnosed wound complication
|
2.7 Number of Visits per participant
Interval 1.0 to 7.0
|
2.9 Number of Visits per participant
Interval 1.0 to 7.0
|
|
Additional Provider Visits
Number of visits - no diagnosed wound complication
|
.8 Number of Visits per participant
Interval 0.0 to 3.0
|
1.4 Number of Visits per participant
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: At randomization.Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Number of Participants With Primary Versus Repeat Cesarean
BMI less than 30 - repeat cesarean delivery
|
64 Participants
|
67 Participants
|
|
Number of Participants With Primary Versus Repeat Cesarean
BMI 30 or greater - repeat cesarean delivery
|
126 Participants
|
132 Participants
|
|
Number of Participants With Primary Versus Repeat Cesarean
BMI 30 or greater - primary cesarean delivery
|
109 Participants
|
106 Participants
|
|
Number of Participants With Primary Versus Repeat Cesarean
BMI less than 30 - primary cesarean delivery
|
71 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Time of CesareanDuration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Intraoperative Trial Details - Duration of Operation and Skin Closure
Duration of Operation
|
58.5 Minutes
Interval 46.5 to 75.0
|
51 Minutes
Interval 40.0 to 65.0
|
|
Intraoperative Trial Details - Duration of Operation and Skin Closure
Duration of Skin Closure
|
15 Minutes
Interval 12.0 to 19.0
|
6 Minutes
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: Time of CesareanNumber of participants requiring subcutaneous tissue closure
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Intraoperative Trial Details - Closure of Subcutaneous Tissue
|
201 Participants
|
202 Participants
|
SECONDARY outcome
Timeframe: Immediate postpartum.Length of hospital stay (days)
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Length of Hospital Stay
|
4.4 Days
Interval 1.0 to 8.0
|
4.5 Days
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: Within 24 hours postpartum.Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Number of Participants That Received Anticoagulation Within 24 Hours
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Immediate postpartum.Number of participants diagnosed with endomyometritis requiring antibiotics
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Number of Participants Diagnosed With Endomyometritis
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 72 hours before and 24 hours after cesarean.Median change in hemoglobin from preoperative value (g/dL) to post-operatively.
Outcome measures
| Measure |
Suture
n=370 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Change in Hemoglobin Pre-operatively to Post-operatively
|
-1.8 g/dL
Interval -2.5 to -1.2
|
-1.8 g/dL
Interval -2.5 to -1.1
|
SECONDARY outcome
Timeframe: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.
Outcome measures
| Measure |
Suture
n=137 Participants
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=138 Participants
Interrupted Ethicon Staples
|
|---|---|---|
|
Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.
|
12 score on a scale
Interval 9.0 to 15.0
|
13 score on a scale
Interval 9.0 to 16.0
|
Adverse Events
Suture
Staples
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suture
n=370 participants at risk
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
|
Staples
n=376 participants at risk
Interrupted Ethicon Staples
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Wound Complications
|
4.9%
18/370 • Number of events 18 • Adverse events were monitored from the time of randomization to 30 days postpartum.
|
10.6%
40/376 • Number of events 40 • Adverse events were monitored from the time of randomization to 30 days postpartum.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place