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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound; Tissue Adhesion
• Intervention / Treatment: Device: Tissue Adhesives; Procedure: Subcuticular Skin 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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital & Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tissue Adhesives Only; 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.	Device: Tissue Adhesives; No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin
Active Comparator: Subcuticular Suture Closure Method Only; 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.	Procedure: Subcuticular Skin Closure; We will only close the subcuticular layer with suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incision closure time	The time of each closure method will be recorded and compared.	30 minutes

Collaborators and Investigators

• Sponsor: St. John Hospital & Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: March 23, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Cicatrix; Surgical Wound; Tissue Adhesions
• Other Study ID Numbers: StJohnHMedCtr

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes