NCT07167199

Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
PROCEDURE	Subcuticular monocryl suture	Under the skin suture placed by hand
DEVICE	Subcuticular absorbable staple using Insorb device	Under the skin stapling device that delivers absorbable staples

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-09-11
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study