The effect of CUTICERIN® with or without a Regenerative Epithelial Suspension (RES™), on pigmentation of donor sites in children: The pilot randomised DRESSIng Trial
Not Applicable
Recruiting
- Conditions
- Paediatric BurnsInjuries and Accidents - Burns
- Registration Number
- ACTRN12620000227998
- Lead Sponsor
- Department of Industry , Innovation and Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1.Acute burn injury requiring a split thickness skin graft for which:
a.The donor site for evaluation should not exceed 320 sqcm.
b.The split-thickness skin graft recipient site for evaluation should not exceed 400 sqcm.
2.Child (and/or accompanying guardian) is willing and able to complete all follow-up evaluations required by the study protocol.
Exclusion Criteria
Non-English-Speaking Background
2.Child in the care of the Department of Community Services
3.Full thickness skin graft
4.Hypersensitivity to trypsin or sodium lactate.
5.Previous adverse reaction to general anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Donor site pigmentation at 12 months post-split thickness skin graft: Lightness (L*)<br> <br>This will be measured objectively with the DSM II ColorMeter using the CIELab colour space system and colour item of the Manchester Scar Scale(MSS). The primary approach for pigmentation will be Lightness (L*). The difference between L*(donor site) and L*(normal skin) at 12 months post skin graft will be calculated. Blinded review by panel of burns clinicians and rating of two dimensional images of donor site and contralateral normal skin (where possible) using the Manchester Scar Scale colour item.[ Twelve months post skin graft.<br>Assessment of pigmentation will be made at baseline then 3, 6 and 12months post skin graft. ]
- Secondary Outcome Measures
Name Time Method