Trial Outcomes & Findings for Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery (NCT NCT05112640)

NCT ID: NCT05112640

Last Updated: 2024-08-21

Results Overview

Total time for the procedure

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 117 participants
• Primary outcome timeframe: Start of surgery through end of skin closure in minutes
• Results posted on: 2024-08-21

Participant Flow

A total of 117 participants signed the consent, 2 participants withdrew. The study terminated early due to the low accrual.

Participant milestones

Measure	Suture Wound Closure Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Overall Study STARTED	59	56
Overall Study COMPLETED	59	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Baseline characteristics by cohort

Measure	Suture Wound Closure n=59 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=56 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples	Total n=115 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 5 • n=5 Participants	31.1 years STANDARD_DEVIATION 5.2 • n=7 Participants	30.3 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	56 Participants n=7 Participants	115 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	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	56 participants n=7 Participants	115 participants n=5 Participants

PRIMARY outcome

Timeframe: Start of surgery through end of skin closure in minutes

Total time for the procedure

Outcome measures

Measure	Suture Wound Closure n=59 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=56 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Operating Time	69.2 Minutes Standard Deviation 23.7	61.9 Minutes Standard Deviation 21.2

SECONDARY outcome

Timeframe: Time of surgery through six weeks post partum

A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.

Outcome measures

Measure	Suture Wound Closure n=28 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=22 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Wound Cosmesis	3.9 score on a scale Standard Deviation 1.0	3.2 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Time of surgery through six weeks post partum

Population: Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers

Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers

Outcome measures

Measure	Suture Wound Closure n=59 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=56 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Number of Participants With Composite Wound Complication	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 5-10 days

Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart.

A score of 0 means no pain, and 10 means the worst pain.

Outcome measures

Measure	Suture Wound Closure n=49 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=52 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Post Operative Pain	.9 Units on a scale Standard Deviation 2.2	.7 Units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Time of surgery through six weeks post partum

Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis

Outcome measures

Measure	Suture Wound Closure n=49 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=52 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Number of Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time of surgery through six weeks post partum

Population: Patients who had follow up who were sent to triage for evaluation

Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures

Outcome measures

Measure	Suture Wound Closure n=49 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=52 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Use of Resources	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Time of surgery through six weeks post partum

The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.

Outcome measures

Measure	Suture Wound Closure n=48 Participants Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand	Absorbable Staple Wound Closure n=43 Participants Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples
Skin Closure Time in Minutes	7.6 minutes Standard Deviation 2.7	4.1 minutes Standard Deviation 2.67

Adverse Events

Suture Wound Closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Absorbable Staple Wound Closure

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

Brett Goldman

University of Texas Medical Branch

Phone: 9542632359

Email: brettryangoldman@gmail.com

Results disclosure agreements

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