This seems to be the first clinical trial of its kind underway directly comparing the vascularisation of Novosorb BTM vs Integra's biological. Recruitment begins June 1st 2020 until June 1st 2021. I have attached the proposed thesis (all 71 pages) which outlines in depth the direct comparisons between the two products and the proposed research protocol under section 3.1. For those who can be bothered, it is a great summary of current evidence; with an in-depth literature review under section 2.1.
This is the proposed protocol of the clinical trial with enrolment already underway.
Problem: The current standard of care for patients with acute burns at many institutions involves skin grafting. The high mortality of these patients is largely due to the loss of skin and its vital physiologic functions. The use of dermal regeneration templates (DRTs) has revolutionized acute burn management by offering temporary closure of extensive wounds.
Purpose: Integra® is currently one of the most popular and well-studied DRTs. The goal of this study is to compare Integra® to a relatively novel DRT called BTM, or biodegradable temporizing matrix. Pilot studies on BTM have demonstrated promising early vascularization profiles, which may consequently improve graft take and decrease infection rates.
Research Questions: Does BTM promote earlier vascularization than Integra®? How will their histological examinations differ at the 4-week time point?
Methods: A prospective, multicenter, single arm study is proposed. 120 subjects between the ages of 18 and 70 years old with full-thickness thermal injuries constituting 20-50% TBSA will be selected from participating centers. Participants are to have either a continuous 16 cm x 8 cm OR two separate, but comparable 8 cm x 8 cm wound areas. Each patient’s adjacent (or similar) areas will be treated with both DRTs (Integra® and BTM) concurrently for direct comparison of performance.
Outcomes: The wounds will be photographed for matrix integration every 2-5 days for up to 4 weeks, or until complete (100%) vascularization. Benefit: Use of BTM as a DRT in two-stage skin grafting may benefit patients with extensive burns not only by shortening hospital stay, but also by improving long-term cosmesis.
I have attached the thesis below; please let me know if the upload did not work.
BTM vs Integra.pdfCheers, jkg
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