NCT05112640

Subcuticular 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: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: 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 UTMB. 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

• Operative Time
• Wound Heal

Interventions

Type	Name	Description
DEVICE	INSORB: subcuticular stapling device	Under the skin stapling device that delivers absorbable staples
DEVICE	Subcuticular monocryl suture manufactured by Ethicon	Under the skin suture placed by hand

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2021-11-09
• Last updated: 2024-08-21
• Results posted: 2024-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study