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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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Surgical Wound Tissue Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The evaluators of cosmesis will be blind to the group assignment. The person who will evaluate the scars will be a nurse or medical assistant.

Study Groups

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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.

Group Type EXPERIMENTAL

Tissue Adhesives

Intervention Type DEVICE

No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin

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.

Group Type ACTIVE_COMPARATOR

Subcuticular Skin Closure

Intervention Type PROCEDURE

We will only close the subcuticular layer with suture

Interventions

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Subcuticular Skin Closure

We will only close the subcuticular layer with suture

Intervention Type PROCEDURE

Tissue Adhesives

No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes