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Recruiting NCT06713772

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

Trial Parameters

Condition Skin Wound
Sponsor National University of Malaysia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 90
Sex ALL
Min Age 1 Day
Max Age 18 Years
Start Date 2024-08-26
Completion 2025-03-31
Interventions
Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USASteri-StripsTM (3M, St. Paul, Minnesota, USAMonosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * patient with known allergy to cyanoacrylate * patients receiving chemotherapy, immunosuppression, systemic corticosteroids, or with known malignancy

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