None listed
Conditions
Brief summary
The purpose of the whole research program is to evaluate the feasibility of replacing several high cost materials currently in use for burn management at the RAH (Integra, Matriderm, Biobrane/cadaver allograft for burn wound temporisation after excision) with a cost-effective, synthetic alternative. This new material has demonstrated superior efficacy in large animal studies and two pilot human trials in non-burn wounds are currently ongoing. This will represent the first stage of a proposed two-stage strategy to abolish the need for split skin grafts in burn care. The second stage is already at an advanced stage of development in-vitro and has similarly proven effective in porcine wounds.
Interventions
Once the non-viable burned skin/tissue is excised surgically, the BTM will be surgically implanted into the healthy wound bed and held with surgical staples before being over-dressed. Dressing changes every three days will allow observaton and monitoring of the progress of integration of the dermal component (a biodegradable polyurethane foam). After 3 - 6 weeks, following complete integration of the permanent 'dermal' component of the material, its temporary 'epidermal component (a bonded, supe
Once the non-viable burned skin/tissue is excised surgically, the BTM will be surgically implanted into the healthy wound bed and held with surgical staples before being over-dressed. Dressing changes every three days will allow observaton and monitoring of the progress of integration of the dermal component (a biodegradable polyurethane foam). After 3 - 6 weeks, following complete integration of the permanent 'dermal' component of the material, its temporary 'epidermal component (a bonded, superficial, non-biodegradable polyurethane film) will be removed, the underlying 'neodermal' surface refreshed by dermabrasion and definitive closure afforded by the application of a thin, split-thickness skin graft. Graft take and subsequent quality will form long-term outcomes
Sponsors
The Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Deep (deep-dermal and full-thickness) burn injuries between 20 and 50% TBSA requiring burn excision and split skin grafting Age between 18 and 70 years inclusive
Exclusion criteria
Pregnancy Unable to provide informed consent Known allergy/previous reaction to polyurethane dressings
Outcome results
None listed