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 | Recruiting

• 1 other identifier: FF-2024-290
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Wound

Outcome Measures

Primary Outcomes (1)

• Skin closure time

  Skin closure time will be measured using stopwatch and documented in unit minutes and seconds. It will include the time taken for dressing application, but will not include the time taken for subcutaneous layer closure

  Day 0

Secondary Outcomes (5)

• Parents' satisfaction

  Day 7 and 1 month post operation

• Post operative mental health (Post operative pain)

  Day 1 to day 7

• Post operative mental health (Patient's fear towards wound management post operation)

  Day 0 and day 7

• Wound cosmesis

  Day 7 and 1 month post operation

• Wound complication

  Day 7 and 1 month post operation

Study Arms (3)

Group A - Adhesive glue

ACTIVE COMPARATOR

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

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

Group B - Adhesive tape

ACTIVE COMPARATOR

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

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

Group C - Suture

ACTIVE COMPARATOR

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

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

Interventions

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

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

Group A - Adhesive glue

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

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

Group B - Adhesive tape

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

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

Group C - Suture

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

HUKM

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Study Officials

• Marjimin Binti Osman

  HUKM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: December 3, 2024
• Study Start: August 26, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)