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

Not Applicable

Completed

• Conditions: Surgical Wound; Tissue Adhesion
• Interventions: Device: Tissue Adhesives; Procedure: Subcuticular Skin Closure

• Registration Number: NCT03891004
• Lead Sponsor: St. John Hospital & Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2018-03-18
• Study Start: 2018-03-20
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted QC: 2019-03-23
• Study First Posted: 2019-03-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

• Women, ages 18 years and older, undergoing any urogynecologic robotic procedure at St. John Hospital and Medical Center from March 19, 2018 - November 30, 2018.

Exclusion Criteria

• We will exclude women with active skin infections as they may contribute to poor wound healing and infections. We will also exclude procedures that are converted to laparotomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue Adhesives Only	Tissue Adhesives	For the tissue adhesive, we will use Dermabond, which was FDA approved for skin closure in 1998. We will record the length of time of each closure method for comparison, and have patients follow-up at two, six and 12 weeks. At the 12 week visit we will score the appearance of the incision.
Subcuticular Suture Closure Method Only	Subcuticular Skin Closure	For the suture arm we will only close the subcuticular layer. We will record the length of time of each closure method for comparison, and have patients follow-up at two, six and 12 weeks. At the 12 week visit we will score the appearance of the incision.

Primary Outcome Measures

Name	Time	Method
Incision Cosmesis	12 weeks	Our primary outcome measure is to compare incision cosmesis between the two closure methods at the 12 week postoperative visit. The Stony Brook Scar Evaluation scale is used. A point is awarded in each of the following categories: width, height, color, hatch/suture marks, overall appearance. Poorer cosmesis is indicated by a lower score. Highest score possible is 5 points.

Secondary Outcome Measures

Name	Time	Method
Incision closure time	30 minutes	The time of each closure method will be recorded and compared.

Trial Locations

Locations (1)

St. John Hospital & Medical Center; 🇺🇸 Detroit, Michigan, United States