Wound healing and scarring assessment following application of bioengineered skin in burn patients

Not Applicable

• Conditions: Burn injury; Injuries and Accidents - Burns

• Registration Number: ACTRN12623000349640
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-05
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

(1)Patient suffering thermal deep dermal or full thickness burn injuries involving >20% total body surface area (TBSA) requiring excision and grafting.
(2)Patient aged 18-70 years of age.
(3)Patient has deep dermal or full thickness burn injuries on anterior trunk, upper and/or lower limbs (non-weight bearing and not over joints)
(4)Patient agrees to all required follow up procedures and visits.
(5)Patient or legal representative provides written informed consent.

Exclusion Criteria

(1)Patient with burns solely confined to the following excluded anatomical sites: palms, back of trunk, face, neck and soles of feet.
(2)Females who are pregnant or breastfeeding.
(3)Patient with a history of allergy or previous reaction to polyurethane dressing materials, relevant antimicrobial agents or materials of bovine or murine origin.
(4)Patient with severe burn injury and high risk of death.
(5)Patient with a concomitant medical condition with a life expectancy of less than 12 months ie advanced malignancy.
(6)Patient with a pre-existing infection which may interfere with the integration of HSE.
(7)Patient who has expressed a refusal to participate.
(8)Patients who are participating in another clinical trial which has the potential to affect the outcome of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary performance outcome is the percentage take rate of applied HSE (area healed as a percentage of areas grafted) which will be assessed at clinical review by wound measurements, and with progressive clinical photographs, for direct comparison.[7-10 days post closure with HSE <br>1 month post closure with HSE <br>6 months post closure with HSE <br>12 months post closure with HSE ];Primary safety outcome is the incidence of adverse device effects (ADEs) collected throughout the clinical investigation. These will be assessed via clinician review, reviewing electronic medical records and by participant self-reporting throughout the study. Examples of possible adverse events include failure of HSE to integrate or achieve wound closure, infection, rash, discomfort or itch, serous fluid or blood under HSE, wound or joint contraction.[Duration of study: Adverse device events will be recorded at any time throughout the study, for a maximum of 12 months post burn injury closure with HSE.]