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

Primary Purpose

Surgical Wound, Tissue Adhesion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subcuticular Skin Closure
Tissue Adhesives
Sponsored by
St. John Hospital & Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • St. John Hospital & Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tissue Adhesives Only

Subcuticular Suture Closure Method Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incision closure time
The time of each closure method will be recorded and compared.

Full Information

First Posted
March 18, 2018
Last Updated
April 2, 2019
Sponsor
St. John Hospital & Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03891004
Brief Title
Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
Official Title
Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. John Hospital & Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Tissue Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tissue Adhesives Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Subcuticular Suture Closure Method Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Subcuticular Skin Closure
Intervention Description
We will only close the subcuticular layer with suture
Intervention Type
Device
Intervention Name(s)
Tissue Adhesives
Intervention Description
No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin
Primary Outcome Measure Information:
Title
Incision Cosmesis
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incision closure time
Description
The time of each closure method will be recorded and compared.
Time Frame
30 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females as this pertains to skin closure of robotic urogynecology procedures
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States

12. IPD Sharing Statement

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

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