None listed
Conditions
Brief summary
The purpose of the study is to assess a new type of closure for deep burn injury. It will evaluate the safety and efficacy of bioengineered human skin equivalent (HSE) for the closure of full thickness wounds in burn patients requiring excision and skin grafting, and will compare the outcomes with areas treated with standard split skin grafting. HSE is skin which is constructed in a laboratory, using skin cells, which have been extracted from a participant’s skin sample. This project involves using and comparing two variations of the HSE, as well as using standard burns treatment, and assessing the outcomes. The participant may receive one or both variations of the HSE, and will also receive split skin grafting to some of their burns. The three different possible treatments for the participant's burn wounds are: • HSE using platelet hydrogel, which is made with platelets supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process. These are combined with a hydrogel, which is a water soluble sheet used to grow the skin cells. • HSE using Novosorb® polyurethane polymer, which is a biodegradable foam, widely used in the treatment of burns. • The remaining burn areas will be treated with split skin grafts. The participant will have skin grafts applied to some of their burn injuries. The treated areas are subsequently assessed and photographed at 7-10 days post HSE application, 4 weeks post HSE application, 6 months post HSE application, and 12 months post HSE application.
Interventions
The two treatments being assessed are bioengineered human skin equivalent (HSE) incorporating platelet derived hydrogel, with or without serum; and bioengineered HSE using polyurethane polymer.
The main difference between the two HSE treatments are that HSE using platelet hydrogel, which is made with platelets which are supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process; and HSE using NovoSorb polyurethane polymer, which is
The two treatments being assessed are bioengineered human skin equivalent (HSE) incorporating platelet derived hydrogel, with or without serum; and bioengineered HSE using polyurethane polymer. The main difference between the two HSE treatments are that HSE using platelet hydrogel, which is made with platelets which are supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process; and HSE using NovoSorb polyurethane polymer, which is a biodegradable foam, which is widely used in the treatment of burn injury. The participants will receive either one or both treatments to their burn injuries. This is an open label study where the areas treated are known to the investigators, and the areas treated with HSE will be determined by clinician's discretion. Treatment will occur in the Alfred Hospital's Operating Suite by a Burns Surgeon, and HSE may be applied on more than once occasion if there is a complication which results in the initial HSE failing to take. The length of time taken for HSE application will vary from patient to patient, and will be determined by the extent of their burn injury and the number of HSE grafts applied. Follow up is at 1-2 weeks, 4-6 weeks, 3 months, 6 months and 12 months post HSE application.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Outcome results
None listed