Trial Outcomes & Findings for Staples Versus Suture for Cesarean Wound Closure (NCT NCT01008449)

NCT ID: NCT01008449

Last Updated: 2014-09-03

Results Overview

this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 398 participants
• Primary outcome timeframe: 4-6 weeks post partum
• Results posted on: 2014-09-03

Participant Flow

Participant milestones

Measure	Absorbable Subcuticular Surgical Suture Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Overall Study STARTED	200	198
Overall Study COMPLETED	171	179
Overall Study NOT COMPLETED	29	19

Reasons for withdrawal

Measure	Absorbable Subcuticular Surgical Suture Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Overall Study Lost to Follow-up	29	19

Baseline Characteristics

Staples Versus Suture for Cesarean Wound Closure

Baseline characteristics by cohort

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.	Total n=350 Participants Total of all reporting groups
Age, Continuous	26.9 years STANDARD_DEVIATION 5.9 • n=5 Participants	26.7 years STANDARD_DEVIATION 6.1 • n=7 Participants	26.8 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	171 Participants n=5 Participants	179 Participants n=7 Participants	350 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	171 participants n=5 Participants	179 participants n=7 Participants	350 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 weeks post partum

this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Percent of Subjects With Composite Wound Morbidity.	5.9 percentage of subjects	14.5 percentage of subjects

SECONDARY outcome

Timeframe: at the end of follow up, 4 - 6 weeks post partum

The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))	4 units on a scale Interval 3.0 to 5.0	3 units on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: Intraoperative, at time of intervention.

time for procedure as measured in minutes

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Operative Procedure Time.	40 minutes Interval 28.0 to 55.0	37 minutes Interval 29.0 to 53.0

SECONDARY outcome

Timeframe: at end of follow-up, 4 - 6 weeks post partum

the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Post Operative Pain - 4 - 6 Weeks Post Delivery	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 72 - 96 hours post delivery

the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Post Operative Pain - 72 - 96 Hours Post Delivery	5 units on a scale Interval 4.0 to 7.0	5 units on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 4 - 6 weeks post delivery

Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Subject Reported Satisfaction With Appearance of Scar	4 units on a scale Interval 4.0 to 5.0	4 units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: at end of follow-up, 4 - 6 weeks post partum

Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Subject Satisfaction With Comfort With Scar	4 units on a scale Interval 4.0 to 5.0	4 units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: at end of follow-up, 4 - 6 weeks post partum

Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar

Outcome measures

Measure	Absorbable Subcuticular Surgical Suture n=171 Participants Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 Participants Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Subject Satisfaction With Location of Scar	4 units on a scale Interval 4.0 to 5.0	4 units on a scale Interval 4.0 to 5.0

Adverse Events

Absorbable Subcuticular Surgical Suture

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Surgical Staples

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Absorbable Subcuticular Surgical Suture n=171 participants at risk Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries. Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.	Surgical Staples n=179 participants at risk Patients in this arm will receive surgical staples for wound closure. Surgical staples: Surgical staples will be used once for wound closure.
Infections and infestations infection at 4 - 6 weeks post delivery	3.5% 6/171	2.2% 4/179
Skin and subcutaneous tissue disorders disruption of wound at 4 - 6 weeks post delivery	3.5% 6/171	13.4% 24/179

Additional Information

Principal Investigator

UAB

Phone: 205-934-3411

Email: dana_figueroa_marzilli@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place