At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
In Brief
A Phase 2 clinical trial evaluating 4-0 monofilament suture and Stainless steel staples for Wound Infection and Wound Complication. Completed, enrolled 173 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Skin closure using 4-0 monofilament suture
Skin closure using stainless steel staples.