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

July 8, 2021 updated by: Yonsei University

A Prospective Randomized Controlled Trial Comparing Cyanoacrylate Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY DESIGN

  1. Screening: replaced with preoperative examination

    • chest X-ray, CBC, CEA, BUN/Cr, OT/PT, glucose, EKG, abdominopelvic CT (optional), chest CT (optional), PET-CT(optional), MRI(optional)

  2. Subject

    • Experimental group: surgical wound closure with liquid skin adhesive
    • Control group: surgical wound closure with stapler
  3. Randomization The patients were randomized just before surgery after anesthesia and were randomly assigned to either experimental or control group as to computer-generated random number in 1:1 manner.

  4. Study schedule

    • The enrolled patients received an elective surgery within 30 days after screening.
    • Surgical wound managers checked every enrolled patient from immediate postoperative period until discharge at least 1 time per day. Surgical wound managers were either surgical hospitalists (general surgery boards), surgical residents, or wound care specialist nurses. Incompletely healed wounds until discharge were managed regularly in out-patient clinics additionally. If wound complications were noted at any time point, standard treatment was given according to the patient's status regardless of assigned groups

  5. Wound management

    • Wound healing time was defined as the time period from the moment of skin closure to the point when a surgical wound manager declared that the wound was healed either during admission or in out-patient clinic. For LSA group, wound closure time was measured in second starting from when LiquiBand® was applied to the first skin incision to when LiquiBand® was completely dried up in all skin incisions. For stapler group, it was measured as the whole time in second spent to apply skin staplers to all skin incisions in about 1cm interval without any dehiscence.
    • Surgical wound management was performed at least once a day in all patients. Wound management time was measured when surgical wound manager inspected and performed wound dressing as required. It was defined as time in second starting from the moment a patient completely took off tops to the moment a surgical wound manager took off gloves on the completion of dressing.
    • The complete wound healing was declared by surgical wound managers for wounds that have injections less than 2mm, no skin color change on the edges, no dehiscence on the inspection under white light.
    • Wound management time and cost were analyzed separately for event places (during admission - and out-patient clinic). Wound management time was compensated as to surgical wound managers and converted in to man-hour. The compensation constant was defined to reduce bias by performer assuming the skill level of wound management was different among surgical wound managers. The surgical hospitalists who were general surgery boards were found to be the most skillful, therefore the constant for them was defined as 1. The constants for surgical residents and wound care specialist nurses were defined as 0.6 and 0.8 respectively.
    • The total wound management cost included dressing fee and material cost. Generally, for normal wounds, adhesive foam dressings were used and for complicated wounds, gauzes and vicryl sutures were used as necessary. In Korean National Insurance System, dressing material costs were classified as the benefit service charge which was reimbursed by National Health Insurance Cooperation (NHIC) and the non-benefit service charge which a patient should pay all. Every dressing material was check whether the benefit service or the non-benefit service and the cost was recorded accordingly.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A. 19-year-old or older adults B. elective laparoscopic or robotic colorectal resection C. clean-contaminated surgery without any intraoperative contamination D. The longest incision should be 15cm or shorter E. participant should voluntarily sign inform consent form

Exclusion Criteria:

A. emergency surgery or conversion-to-open surgery B. the longest skin incision longer than 15cm C. intraoperative contamination due to intestinal perforation or any other reason D. ECOG grade 3 or higher E. patients who are not be able to receive surgery within 30 days after screening F. patients who are refused to sign the informed consent form voluntarily

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LSA (liquid skin adhesive)
surgical wound closure with liquid skin adhesive (LiquiBand®)
Procedure: LSA (liquid skin adhesive)
surgical wound closure with liquid skin adhesive (LiquiBand®)
ACTIVE_COMPARATOR: Stapler
surgical wound closure with stapler
Procedure: stapler
surgical wound closure with stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total management time of surgical wound
Time Frame: postoperative day 60

Wound management time was defined as the time period from the moment of skin closure to the point when the wound was healed either during admission or in out-patient clinic. For LSA group, skin closure time was measured in second starting from when LiquiBand® was applied to the first skin incision to when LiquiBand® was completely dried up in all skin incisions. For stapler group, it was measured as the whole time in second spent to apply skin staplers to all skin incisions in about 1cm interval.

Wound management was performed at least once a day in all patients. Time was measured when surgical wound manager inspected and performed wound dressing as required. It was defined as time in second starting from the moment a patient completely took off tops to the moment a surgical wound manager took off gloves on the completion of dressing.
postoperative day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical wound related complication
Time Frame: postoperative day 60
Surgical wound related complication is classified as erythema, edema, tenderness, inflammation, discharge, surgical site infection and dehiscence.
postoperative day 60
Total management costs of surgical wound
Time Frame: postoperative day 60
The total wound management cost included dressing fee and material cost. Generally, for normal wounds, adhesive foam dressings were used and for complicated wounds, gauzes and vicryl sutures were used as necessary. In Korean National Insurance System, dressing material costs were classified as the benefit service charge which was reimbursed by National Health Insurance Cooperation (NHIC) and the non-benefit service charge which a patient should pay all. Every dressing material was check whether the benefit service or the non-benefit service and the cost was recorded accordingly.
postoperative day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Byung Soh Min, Severance Hospital, Yonsei University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 18, 2020

Primary Completion (ANTICIPATED)

October 22, 2021

Study Completion (ANTICIPATED)

October 22, 2021

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (ACTUAL)

July 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2020-1023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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