NCT04969016

A Study Comparing Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection

Status unknown NA Last updated 20 July 2021

What this trial tests

NA trial testing LSA (liquid skin adhesive) in Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection in 58 participants. Status unknown.

Timeline

18 November 2020

Primary endpoint
22 October 2021

22 October 2021

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	18 November 2020
Primary completion	22 October 2021
Estimated completion	22 October 2021
Sites	1 location across South Korea

Drugs / interventions tested

• LSA (liquid skin adhesive)
• stapler

Conditions studied

• Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection — all drugs for Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection →

Sponsor

Yonsei University

Who can join

19 and older, any sex, with Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

INTRODUCTION

Liquid skin adhesive (LSA) has benefits over other closure methods. Especially it is less invasive, quicker to apply, and better in cosmesis. Also LSA applied wounds need no post-care and its water-proof nature allows patients to take a shower immediate postoperative periods. While traditional sutures and skin staples are invasive and have infection chance requiring regular wound dressings, LSA is resistant against both water and microbial infection without need for postoperative dressings. Thus LSA-applied wounds need no professional care saving wound management cost.

This study investigated not only the safety and efficacy of LSA, but also the cost-effectiveness in the context of total wound management resources including man-power, time, and cost.

STUDY OBJECTIVE

Primary end point of this study is time requiring to manage surgical wound calculated as man hour. Secondary end points are wound related complication and cost for management of surgical wound.

STATISTICAL ANALYSIS

The target number of the enrollment were calculated under the hypothesis that the wound management time for stapler group would be 1560 sec and that for LSA group be 264 sec with 10% drop-out rate. The sample number calculation formula of the t-test for independent 2 groups were used. For two-sided validation with the significance level of 0.05, and the power of 0.8, 29 patients for each group were estimated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized controlled trial comparing liquid skin adhesives and staplers for surgical wound management.
   Bae HW, Yang SY, Ku GY, Lee S, et al · · 2025 · PMID 40083984 · DOI 10.4174/astr.2025.108.3.143