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

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891004
• Other study ID #: StJohnHMedCtr
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: St. John Hospital & Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound
• Tissue Adhesion
• Tissue Adhesions

Intervention

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

Locations

Country	Name	City	State
United States	St. John Hospital & Medical Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
St. John Hospital & Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incision Cosmesis	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.	12 weeks
Secondary	Incision closure time	The time of each closure method will be recorded and compared.	30 minutes