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Clinical Trials/NCT03891004
NCT03891004
Completed
Not Applicable

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

St. John Hospital & Medical Center1 site in 1 country47 target enrollmentMarch 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Wound
Sponsor
St. John Hospital & Medical Center
Enrollment
47
Locations
1
Primary Endpoint
Incision Cosmesis
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2018
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
St. John Hospital & Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Sunetris Fluellen

Principal Investigator

St. John Hospital & Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Incision Cosmesis

Time Frame: 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 Outcomes

  • Incision closure time(30 minutes)

Study Sites (1)

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