None listed
Conditions
Brief summary
The primary purpose of the study is to evaluate the safety and performance of a novel, biodegradable dermal matrix for the treatment of patients with deep burns (deep-dermal/full-thickness injuries) involving 10-70% total body surface area (TBSA) requiring burn excision and significant skin grafting. Current standard of care for deep partial or full-thickness burns includes early excision of necrotic tissue and prompt coverage. This attenuates the postburn hypermetabolic response, decreases fluid loss, and ultimately improves survival. A full thickness autograft (skin transplant) is used to cover the debrided wound. However, if the extent of the burns is very severe, then this approach becomes impracticable, there is not enough healthy skin left to harvest and the patient is already too unwell to cope with another large wound. For moderate to large burn injuries in subjects, grafting at a second operation allows significant physiological recovery of the subject prior to graft harvest and application. Reducing the early surgical ‘insult’ to major burn injury sufferers is important in assisting patient survival and reduces the risk of loss of resources (such as harvested applied skin grafts and skin graft donor sites) secondary to physiological insufficiency or deterioration. The Biodegradable Temporising Matrix (BTM), manufactured and assembled by PolyNovo Biomaterials Pty Ltd has been designed specifically for use in extensive full thickness burn injuries, but its structure and properties make it suitable for other full thickness wounds where dermal reconstruction is necessary or desirable.
Interventions
The BTM wound dressing is composed of polyurethane materials, 2mm in thickness and is available in multiple sizes.
A qualified surgeon will administer the following procedures:
The wound bed must be cleaned with no devitalized tissue present. The BTM foam side is pressed into the wound, held with surgical steel staples and then applied with overlying dressing and crepe bandages. Dressings are changed every 3-5 days.
The BTM may be ready for grafting by 3-5 weeks. The BTM membrane is removed (
The BTM wound dressing is composed of polyurethane materials, 2mm in thickness and is available in multiple sizes. A qualified surgeon will administer the following procedures: The wound bed must be cleaned with no devitalized tissue present. The BTM foam side is pressed into the wound, held with surgical steel staples and then applied with overlying dressing and crepe bandages. Dressings are changed every 3-5 days. The BTM may be ready for grafting by 3-5 weeks. The BTM membrane is removed (delamination) leaving foam remnants attached to its underside. The wound is refreshed by gentle demabrasion until gently bleeding surface is obtained. A split skin graft is secured to the surface of BTM with staples or sutures and dressed.
Sponsors
PolyNovo Biomaterials Pty Ltd
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
1. Patients suffering thermal burn injuries (deep-dermal/full thickness) involving 10-70% total body surface area (TBSA) requiring excision and split skin grafting. 2. Patients aged 18 - 70 years, inclusive. 3. Patient agrees to all required follow-up procedures and visits. 4. Patient or legal representative provides written, informed consent.
Exclusion criteria
1. Patient with burn(s) solely confined to the following “excluded” anatomical sites: hands, face, neck and soles of the feet. 2. Females who are pregnant or breast-feeding, or who may get pregnant during the period of the study or who are of childbearing potential and unwilling to use a reliable method of contraception 3. Patient with history of allergy or previous reaction to polyurethane dressing materials. 4. Patient with a concomitant medical condition with a life expectancy of less than 12 months (e.g. advanced malignancy). 5. Patient who has a pre-existing infection which may interfere with the take of the matrix. 6. Patient who has expressed a refusal to participate. 7. Patients who are participating in another clinical trial which has the potential to affect the outcome of this study.
Outcome results
None listed