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To Evaluate The Skin Closure Time, Parents' Satisfaction, Post Operative Mental Health, Wound Cosmesis and Wound Complication Of Skin Closure Using Adhesive Glue, Adhesive Tape And Suture In Paediatric Surgery Patients

NCT06713772 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-12-03

No results posted yet for this study

Summary

This study is a randomised controlled trial to evaluate the skin closure time, parents' satisfaction, post operative mental health, wound cosmesis and wound complication of skin closure using adhesive glue, adhesive tape and suture in paediatric surgery patients.

Primary objective is to compare skin closure time required by using adhesive glue, adhesive tape and suture. Secondary objectives are to compare parents' satisfaction, post operative mental health, wound cosmesis and wound complication of skin closure using adhesive glue, adhesive tape and suture in paediatric surgery patients.

This study will be conducted from 26th August 2024 to 31st May 2025. It will take place at Hospital Pakar Kanak-Kanak UKM (HPKK), involving paediatric surgery patients undergoing clean or clean contaminated surgeries.

The sample size calculated is 30 per group, a total of 90 patients for three groups. The sampling method used is simple random sampling method.

In group A, skin will be closed using adhesive glue (Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA). Skin closure in group B will be done using adhesive tape (Steri-StripsTM (3M, St. Paul, Minnesota, USA). In group C, skin will be closed using suture (Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany) 4/0.

Conditions

  • Skin Wound

Interventions

DEVICE

Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA

Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA

DEVICE

Steri-StripsTM (3M, St. Paul, Minnesota, USA

Steri-StripsTM (3M, St. Paul, Minnesota, USA

DEVICE

Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany

Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany

Sponsors & Collaborators

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Marjimin Binti Osman · HUKM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2025-03-31
Completion
2025-05-31

Countries

  • Malaysia

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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 NCT06713772 on ClinicalTrials.gov