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RECRUITING
NCT06713772
NA

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

Sponsor: National University of Malaysia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Day - 18 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-08-26

Completion Date

2025-05-31

Last Updated

2024-12-03

Healthy Volunteers

No

Conditions

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

Locations (1)

HUKM

Cheras, Kuala Lumpur, Malaysia