NCT03891004

Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: St. John Hospital & Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week follow up visit. Secondary outcome is the operative time between the two methods of closure.

Detailed description

The purpose of this study is compare skin closure via suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis. Therefore, if the tissue adhesive is cosmetically comparable to that of sutures, that will be reason to use tissue adhesives over traditional sutures. In these surgeries, there are five to six port sites (compared to fewer for usual laparoscopic procedures) and the procedures are lengthy procedures (average duration about 300 minutes as per recent AUGS/ACOG committee opinion), so if the investigators can show significant time reduction for closure, that should reduce operative time and costs. To the investigators' knowledge, this will be the first study of its kind to make this comparison for urogynecologic robotic procedures.

Conditions

• Surgical Wound
• Tissue Adhesion

Interventions

Type	Name	Description
PROCEDURE	Subcuticular Skin Closure	We will only close the subcuticular layer with suture
DEVICE	Tissue Adhesives	No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin

Timeline

• Start date: 2018-03-20
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2019-03-26
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study