A randomized controlled study of 40 patients found PermeaDerm reduced product cost by 70% and preparation time by 95.7% compared with cadaveric allograft while producing comparable clinical outcomes.
AVITA Medical announced results from its multicenter, randomized controlled PermeaDerm-I study showing that PermeaDerm, a biosynthetic wound matrix used for temporary wound coverage, reduced product cost compared with cadaveric allograft while producing comparable clinical outcomes. The study met its primary endpoint, with a mean treatment cost of $148.70 for every 1% of total body surface area treated with PermeaDerm compared with $497.10 for allograft, a difference of approximately $348 per 1% total body surface area (p<0.001).
Preparation Time Reduced by 95.7%
PermeaDerm reduced preparation time by 95.7% compared with allograft. According to AVITA Medical, the off-the-shelf product does not require tissue tracking, thawing, or meshing. Application time in the operating room was comparable between the two groups.
Clinical outcomes also were comparable. Approximately 94% of patients treated with PermeaDerm achieved at least 95% graft take one week after autografting. All patients in both groups achieved at least 95% wound healing by eight weeks. No adverse events were attributed to PermeaDerm during the study.
“Temporary wound coverage is a critical step between excision and definitive closure when a wound bed is not yet ready for autograft placement,” said Anju Saraswat, MD, associate burn director and assistant professor of surgery at Atrium Health Wake Forest Baptist Burn Center and a study investigator. “These results demonstrate that PermeaDerm provided clinical performance comparable to allograft with the added benefit of product transparency enabling direct visualization of the wound bed. By eliminating tissue bank logistics and preparation time, PermeaDerm offers a more efficient approach to wound temporization without any compromise to healing outcomes and reducing cost.”
Study Included 40 Patients at 11 Burn Centers
The study enrolled 40 patients across 11 U.S. burn centers. Patients with wounds involving up to 30% total body surface area were eligible. Following surgical excision, patients were randomized to receive either PermeaDerm or cadaveric allograft for temporary wound coverage before definitive split-thickness skin grafting.
The primary endpoint evaluated treatment cost per percent total body surface area treated. Secondary endpoints included preparation and application time, graft take, wound healing, inflammatory profile, adverse events, and surgeon and patient satisfaction. Patients were followed for eight weeks after definitive closure.
At final follow-up, all responding investigators and patients reported being satisfied or very satisfied.
PermeaDerm Provides Temporary Wound Coverage
PermeaDerm is a transparent bilayer biosynthetic wound matrix designed to provide temporary coverage between surgical excision and definitive wound closure. Its transparency allows clinicians to view the wound bed without removing the matrix.
“The PermeaDerm-I study establishes compelling clinical and economic evidence supporting PermeaDerm as a modern alternative to allograft,” said Cary Vance, president and chief executive officer of AVITA Medical. “By combining comparable clinical performance with meaningful economic value and a simpler workflow, we believe PermeaDerm addresses an important need for hospitals while strengthening AVITA’s differentiated acute wound care portfolio.”
Photo: ID 176672987 | Lab © Alphaspirit | Dreamstime.com
