Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03891004|
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Tissue Adhesion||Procedure: Subcuticular Skin Closure Device: Tissue Adhesives||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.|
|Masking:||Double (Participant, Outcomes 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.|
|Official Title:||Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures|
|Actual Study Start Date :||March 20, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
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
- 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.
- Incision closure time [ Time Frame: 30 minutes ]The time of each closure method will be recorded and compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891004
|United States, Michigan|
|St. John Hospital & Medical Center|
|Detroit, Michigan, United States, 48236|