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

ConditionSkin Wound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorNational University of Malaysia

About this trial

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.

Eligibility criteria

Qualifiers

patients aged 18 years or less

clean and clean contaminated surgery

wound length of 1-10cm

surgical wound amenable to closure with the three skin closure techniques

Disqualifiers

scrotal or penile incision

contaminated or dirty wound

repeated surgical procedures at the surgical site

wound that is not amenable to primary closure with the three techniques

Trial design

Treatments tested in this trial

  • Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA
  • Steri-StripsTM (3M, St. Paul, Minnesota, USA
  • Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

HUKMRecruiting56000, Cheras, Kuala LumpurMalaysiaMalaysia