Comparing the effectiveness of topical silicone gel and pressure garment therapy interventions to prevent and manage burn scars in children.

Not Applicable

Completed

• Conditions: Injuries and Accidents - Burns; Paediatric burns scars; Physical Medicine / Rehabilitation - Occupational therapy

• Registration Number: ACTRN12616001100482
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-15
• Study Completion: 2018-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Children with a burn injury managed in the acute phase post-burn (up to 16 years of age) or who receive burn scar reconstructive surgery (up to 18 years of age).
Children who require attendance at a scar management clinic after skin healing.
Children who receive skin grafting after a burn injury,
Children with wounds that have not healed by day 17 post-burn.
Children who receive burn scar reconstructive surgery in all body locations.
Children with a TBSA of less than or equal to 40% who are accompanied by a parent or guardian, who is able to provide informed consent.
Children with a cognitive impairment that impedes the ability to communicate will be included, however, will not be required to complete self-report measures. Children and their families who do not speak English will be included but will not be required to complete all self-report measures.

Exclusion Criteria

Children with comorbidities that might influence scar outcomes (such as a dermatological disorder);
Children involved with the Department of Communities (Child Safety) where the burns consultant and/or burn team members consider study involvement to be contraindicated;
Children with isolated facial or ear burns;
Children with isolated genital burns;
Children who are referred to their local health service before scar management is commenced.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scar itch<br>Participant self report on a 0-10 Numeric Rating Scale (NRS)<br>Toronto Pediatric Itch Scale<br>Caregiver report using the Patient Observer Scar Assessment Scale (POSAS) NRS<br>[Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction];Scar thickness<br>- GE Healthcare Ultrasound[Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction]