Clinical Effectiveness of Ovine Forestomach Matrix Graft in Complex Lower Limb Reconstruction and Limb Salvage

This is an IRB-approved interim report of a multi-center, retrospective case series, with full reporting expected Jan 2022. All patients meeting the inclusion/exclusion criteria and included in the case series had undergone surgical reconstruction of complex lower extremity soft tissue defects with an OFM graft. A total of 33 case records were evaluated (n=33) across seven (7) healthcare centers across the United States.

Case records were reviewed to identify; patient co-morbidities, defect etiology (e.g. NSTI, DFU, burn), defect size, presence of exposed structures, CDC contamination score, Wagner score, OFM graft usage, time to 100% granulation tissue, STSG usage, overall time to heal and any post-operative complications. Patient demographics, baseline wound characteristics and healing outcomes were analyzed with descriptive statistics.

As expected, there was a high incidence of co-morbidities included in the cohort such as DM2 (82%), PVD (73%) and PAD (76%). Interim results of the case series found that lower extremity soft tissue defects treated with OFM achieved viable granulation tissue covering exposed vital structures effectively shortening overall treatment times. The median number of applications to achieve 100% granulation tissue over exposed bone and tendon was 1 (one).

Median time to 100% granulation tissue over exposed bone and tendon was 15.5 days (mean; 16.2+/-6.6 days). Of those patients that received a STSG, mean % STSG take at 1 week was 67+/-13%. All patients went on to heal, with no surgical complications reported. This case series demonstrates OFM as a clinically effective treatment modality in the surgical management of complex lower extremity soft tissue defects with exposed structures. A single application of the graft was effective in regenerating well vascularized neodermis, often in the presence of exposed structures within 16.2+/-6.6 days, in a complex patient cohort who might otherwise have lost extremities to amputation (Flood, Weeks et al. 2020).