Randomised controlled trial of donor site dressings in paediatric split skin grafts

Not Applicable

Completed

• Conditions: Paediatric Burns; Surgery - Surgical techniques; Injuries and Accidents - Burns

• Registration Number: ACTRN12614000380695
• Lead Sponsor: Stuart Pegg Paediatric Burns Centre

Brief Summary

This trial was designed to determine which donor site wound dressing was preferred in children. All three dressings in this trial - Sorbact, Algisite M, Cuticerin - were in use in the Pegg Leditschke Children's Burns Centre prior to the trial starting. 101 children were prospectively enrolled in the trial, and characteristics of healing and scarring were assessed with respect to each dressing. There were no significant differences identified across the three dressings; pain, time to re-epithelialisation, itch, scarring, or cost. Younger patients healed more rapidly than older patients. Thinner skin grafts resulted in better scars at three and six months. These data are limited to children, and do not show one dressing to be superior to another. As this is was designed as a superiority trial, we do not have the data to be able to state that each dressing is equivalent.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-08
• Study Completion: 2017-08-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Patients of the Stuart Pegg Paediatric Burns Centre (SPPBC) undergoing split skin grafting for burns

Exclusion Criteria

Aged >15 years of age
Non-English speaking
Cognitive impairment
Current involvement with Department Communities (Child Safety)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to re-epithelialisation assessed in two ways.<br>- Clinical judgement by surgeon treating the patient<br>- Blinded second assessment from digital photographs[Expected 7-14 days];Pain while dressing in situ. Pain at dressing change. Assessed via multiple methods - FACES-R/NRS/FLACC - depending on age of patient.[Expected 7-14 days. Once daily while dressing is on (parent, self report). During clinic visit weekly for nurse report];Cosmetic appearance of donor site by POSAS (Pt and Observor Scar Assessment Scale)<br>3D camera (for depth/height, and colour)<br>Ultrasound (for thickness of scar tissue)[3 and 6 months]