Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Not Applicable

Not yet recruiting

• Conditions: Pregnancy

• Registration Number: NCT07167199
• Lead Sponsor: Inova Health Care Services

Brief Summary

Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics

Detailed Description

This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at Inova. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Study Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Study First Posted: 2025-09-11
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-15
• Study Start: 2025-11-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 237

Inclusion Criteria

• 18-50 years of age
• Women ≥ 24 weeks viable gestation
• Will be undergoing cesarean delivery

Exclusion Criteria

• Patient unwilling or unable to provide consent.
• No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
• Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other
• Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
• Current skin infection
• Coagulopathy
• High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
• Incarcerated individuals
• Intraamniotic infection
• Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operating time	Time from the start of surgery through end of skin closure up to 8 hours	Total time for the procedure

Secondary Outcome Measures

Name	Time	Method
Wound Cosmesis	Up to six weeks post partum	A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks post partum. 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.
Post Operative Pain	up to 3 days post-operatively	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.

Trial Locations

Locations (1)

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States