Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Oct 28, 2020; 10(1): 1-6
Published online Oct 28, 2020. doi: 10.5662/wjm.v10.i1.1
Randomized clinical trial comparing skin closure with tissue adhesives vs subcuticular suture after robotic urogynecologic procedures
Sunetris Fluellen, Kyle Mackey, Karen Hagglund, Muhammad Faisal Aslam
Sunetris Fluellen, Kyle Mackey, Muhammad Faisal Aslam, Department of Obstetrics and Gynecology, Ascension St John Hospital and Medical Center, Detroit, MI 48236, United States
Karen Hagglund, Medical Research, Ascension St John Hospital and Medical Center, Detroit, MI 48236, United States
Author contributions: Fluellen S designed and performed the research study; Mackey K wrote manuscript; Hagglund K performed data analysis; Aslam MF designed research study.
Institutional review board statement: This study was reviewed and approved by Ascension St John Hospital Institutional Review Board, reference number 1165375.
Clinical trial registration statement: This study is registered at clinicaltrials.gov with an ID: NCT03891004.
Informed consent statement: All subjects in this study provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors in this study do not have any conflict-of-interests.
Data sharing statement: Dataset available from the corresponding author at kyle.mackey@ascension.org.
CONSORT 2010 statement: The authors confirm that the manuscript was prepared according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Kyle Mackey, MD, Doctor, Department of Obstetrics and Gynecology, Ascension St John Hospital and Medical Center, 22101 Moross Road, Detroit, MI 48236, United States. kyle.mackey@ascension.org
Received: March 9, 2020
Peer-review started: March 9, 2020
First decision: September 21, 2020
Revised: October 6, 2020
Accepted: October 13, 2020
Article in press: October 13, 2020
Published online: October 28, 2020
Processing time: 231 Days and 2.2 Hours
Abstract
BACKGROUND

Skin closure techniques during minimally-invasive gynecologic surgery is largely based on surgeon preference. The optimum technique would theoretically be safe, rapid, inexpensive, and result in good cosmetic appearance. Cyanoacrylate tissue adhesive (Dermabond) may be a comparable and safe option for port site closure as compared with subcuticular suture. In this randomized clinical trial, we hypothesized that operative time for skin closure would be less than subcuticular suture during robotic urogynecologic procedures.

AIM

To compare skin closure during robotic urogynecologic surgeries for tissue adhesives and subcuticular suture.

METHODS

Fifty female subjects > 18 years of age undergoing robotic urogynecologic procedures were randomized to have port site closure with either cyanoacrylate tissue adhesive (n = 25) or subcuticular suture (n = 25). All procedures and postoperative evaluations were performed by the same board certified Female Pelvic Medicine and Reconstructive Surgeon. Incisional closure time was recorded. Each subject was followed for 12-wk postoperatively. Incision cosmesis was evaluated using the Stony Brook Scar Evaluation Scale.

RESULTS

A total of 47 subjects (cyanoacrylate group, n = 23; suture group, n = 24) completed the 12-wk postoperative evaluation. Closure time was significantly less (P < 0.0005) using cyanoacrylate tissue adhesive (5.4 ± 2.0 min) than subcuticular suture (24.9 ± 5.6 min). Cosmesis scores were significantly higher in the cyanoacrylate tissue adhesive group than subcuticular suture (P = 0.025). No differences were found between bleeding, infection, or dehiscence (P = 1.00, P = 0.609, P = 0.234, respectively). No statistical demographical differences existed between the two study arms.

CONCLUSION

Our study supported our original hypothesis that cyanoacrylate tissue adhesive for port site closure during robotic urogynecolgic procedures uses less time than with subcuticular suture. Our study also supports that tissue adhesive is comparable to cosmetic outcome while not jeopardizing rates of bleeding, infection, or dehiscence.

Keywords: Skin closure in robotic surgery; Dermabond; Cosmesis; Urogynecology; Closure time

Core Tip: This clinical trial study is novel in its investigation of traditional vs innovative skin closure techniques with respect to closure time, cosmesis, and equivalency during urogynecologic robotic procedures. Our study demonstrated a reduction in closure time, improved cosmetic healing while not jeopardizing incidence of wound complications. This supports the use of tissue adhesive as being not only comparable, but also advantageous during closure of robotic urogynecologic procedures.