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

NCT04969016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection

Interventions

PROCEDURE

LSA (liquid skin adhesive)

surgical wound closure with liquid skin adhesive (LiquiBand®)

PROCEDURE

stapler

surgical wound closure with stapler

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Byung Soh Min · Severance Hospital, Yonsei University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2021-10-22
Completion
2021-10-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04969016 on ClinicalTrials.gov