Among 411 patients treated with severe underlying disease, contaminated wounds, or exposed bone and tendon, Aroa Biosurgery recorded a deep tissue infection rate of 0.7% across 474 soft tissue defects in its interim MASTRR Registry analysis, now published in Advances in Therapy. For context on why that number matters: infection rates reported in separately published meta-analyses for resorbable synthetic bioscaffolds used in comparable procedures ranged from 16% to 25%.
The patient population was genuinely difficult. Roughly 59% of participants were ASA Class III or IV, meaning significant systemic disease, and 89% of defects were classified as clean-contaminated or contaminated. Fifteen percent involved confirmed osteomyelitis. Superficial infection occurred in 2.9% of patients, and no infections were attributed to the Myriad products over a median 27-week follow-up. Aroa describes this as the largest published prospective bioscaffold analysis in in-patient soft tissue reconstruction, to its knowledge, covering both FDA-cleared Myriad Matrix and Myriad Morcells across 10 US centers.
The clinical stakes behind the infection numbers are concrete. A large US analysis of open surgical procedures found that a surgical site infection added roughly 7.8 to 9.3 days to hospital stay and between $18,600 and $21,000 in costs per patient, with deep tissue infections carrying heavier consequences still. The MASTRR interim analysis measured safety, not cost outcomes, so direct savings cannot be read from these data. Still, in a patient group where complication rates this low are uncommon, the infection profile gives hospital value committees something specific to consider when the product comes up for formulary review.
The registry remains open, with more than 550 patients enrolled against an 800-patient ceiling across 15 US sites. Earlier MASTRR publications addressed lower extremity reconstruction, trauma, burns, pilonidal disease, and pressure injuries in separate procedure-specific analyses. The next meaningful signal will come from whether the full 800-patient dataset, when complete, sustains the 0.7% deep infection rate across the wider range of surgical specialties Aroa is actively recruiting.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
