NCT01977612

Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

Detailed description

The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI\>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.

Conditions

• Wound Infection
• Wound Complication

Interventions

Type	Name	Description
DEVICE	4-0 monofilament suture	Skin closure using 4-0 monofilament suture
DEVICE	Stainless steel staples	Skin closure using stainless steel staples.

Timeline

• Start date: 2013-05-15
• Primary completion: 2016-06-17
• Completion: 2016-06-30
• First posted: 2013-11-06
• Last updated: 2017-07-31
• Results posted: 2017-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study