Trial Outcomes & Findings for Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery (NCT NCT01509950)

Results Overview

Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Post-operative day 3 or 4.

Results posted on

2019-03-04

Participant Flow

Recruitment into the first two arms (Staples and Prolene non-absorbable sutures) occurred through May 2013. The study protocol was modified in July 2014 and the third arm of the study, absorbable sutures, was added, however, no recruitment occurred after this modification.

Participant milestones

Participant milestones
Measure	Staples Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Overall Study STARTED	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Staples n=7 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=8 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision	Total n=15 Participants Total of all reporting groups
Age, Continuous	33.0 years n=5 Participants	33.5 years n=7 Participants	33.3 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 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 Non-Hispanic White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-operative day 3 or 4.

Population: Only patients with available data were included in the analysis.

Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)

Outcome measures

Outcome measures
Measure	Staples n=3 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=5 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Level of Pain on a Scale During the Post-operative Hospitalization Period	2.0 units on a scale Interval 1.5 to 3.4	2.0 units on a scale Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: Post-operative week 6

Population: Only patients with available data were included in the analysis.

Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Staples n=1 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=3 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Level of Pain on a Scale at 6 Weeks Postpartum	3 units on a scale Interval 3.0 to 3.0	1 units on a scale Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Post-operative week 6

Population: Only patients with available data were included in the analysis.

Wound complications include conditions like infection, seroma/hematoma and dehiscence

Outcome measures

Outcome measures
Measure	Staples n=1 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=3 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Count of Participants With Wound Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-operative day 3 or 4

Population: Only patients with available data were included in the analysis.

Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Outcome measures

Outcome measures
Measure	Staples Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=3 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Level of Patient Satisfaction to the Wound Appearance	—	9 units on a scale Interval 8.5 to 9.0

SECONDARY outcome

Timeframe: Post-operative week 6

Population: There were no patients that had data available for analysis for "staples" and "prolene non-absorbable sutures" study arms.

Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day of cesarean delivery (up to 8 hours)

Measured in minutes

Outcome measures

Outcome measures
Measure	Staples n=7 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=8 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Time From Skin Incision to the Skin Closure	55.0 minutes Interval 46.0 to 61.0	56.5 minutes Interval 54.0 to 62.25

SECONDARY outcome

Timeframe: Post-operative day 3 or 4

Population: Only patients with available data were included in the analysis.

Measured in seconds

Outcome measures

Outcome measures
Measure	Staples n=2 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=4 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Time Needed for the Suture Removal	79.0 seconds Interval 73.5 to 84.5	1.5 seconds Interval 1.0 to 1.75

SECONDARY outcome

Timeframe: Post-operative week 6

Population: Only patients with available data were included in the analysis.

Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)

Outcome measures

Outcome measures
Measure	Staples n=5 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=3 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Level of Patient's Satisfaction to the Cosmesis of the Wound	9.0 units on a scale Interval 8.0 to 10.0	5.0 units on a scale Interval 5.0 to 7.5

SECONDARY outcome

Timeframe: Post-operative day 1

Population: Only patients with available data were included in the analysis.

Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Outcome measures

Outcome measures
Measure	Staples n=2 Participants Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=2 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Level of Patient's Overall Patient Satisfaction to the Type of Closure	8.0 units on a scale Interval 7.5 to 8.5	7.5 units on a scale Interval 6.25 to 8.75

SECONDARY outcome

Timeframe: Post-operative day 3 or 4

Population: Only patients with available data were included in the analysis.

Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Outcome measures

Outcome measures
Measure	Staples Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision	Prolene Non-absorbable Sutures n=3 Participants Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision
Level of Patient's Overall Patient Satisfaction to the Type of Closure	—	8.7 units on a scale Interval 8.5 to 9.0

SECONDARY outcome

Timeframe: Post-operative week 6

Population: No patients had data available for the analysis.

Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)

Outcome measures

Outcome data not reported

Adverse Events

Staples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prolene Non-absorbable Sutures

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

Research Operations Manager

Stanford University

Phone: 6507255720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place