This prospective observational case series at a single level 1 trauma center included nine participants (eight men, one woman) with a total of 12 Stage 3 or 4 pressure injuries. Patients received ovine forestomach matrix (OFM)-based grafts; no comparator group was reported. The primary outcome was the incidence of postoperative complications, and secondary outcomes included time to granulation tissue coverage, time to fill, percent area reduction, and number of OFM applications. Follow-up duration was not reported.
No postoperative complications were observed. The median time to 50% granulation tissue coverage was 2.0 weeks (IQR: 1.5, 8.5), and the median time to complete granulation tissue coverage was 6.5 weeks (IQR: 2.0, 15.0). Tunneling or undermining was eradicated in 50% of pressure injuries. The mean percent area reduction at the last recorded visit was 61% (SD: 30%). Serious adverse events, discontinuations, and overall tolerability were not reported.
Key limitations include the small sample size (nine participants with 12 pressure injuries), absence of a comparator group, and lack of reported follow-up duration. As a single-center case series, these findings are descriptive and cannot establish efficacy or safety compared with standard care. The practice relevance is that OFM-based grafts may serve as an adjunct for surgically managing late-stage pressure injuries that are difficult to heal; however, clinicians should interpret these results cautiously and await comparative data.
View Original Abstract ↓
IntroductionStage 3 and 4 pressure injuries (PIs) pose significant challenges in trauma patients. Surgical management aims to support improvements in tissue vitality and often relies on debridement and negative pressure wound therapy. The use of ovine forestomach matrix (OFM)-based grafts to augment existing surgical approaches may improve tissue quality prior to reconstruction or closure by secondary intention.MethodsThis prospective observational study is part of a larger Institutional Review Board-approved study (Registry: ClinicalTrials.gov. Clinical trial number: NCT05243966). The study enrolled patients with Stage 3 and 4 PIs between July 2022 and July 2024 at a single level 1 trauma center. The study’s primary endpoint was the incidence of postoperative complications and secondary endpoints included time to granulation tissue coverage and/or fill, percent area reduction, and number of OFM applications.ResultsNine participants (eight men, one woman) with a total of 12 PIs (25% Stage 3 and 75% Stage 4) were enrolled in the study. The mean surface area was 46 ± 24 cm2, and 10 of the 12 enrolled PIs included areas of tunneling and/or undermining. The median time to 50% granulation tissue was 2.0 (IQR: 1.5, 8.5) weeks and the median time to complete granulation tissue coverage was 6.5 (IQR: 2.0, 15.0) weeks. Tunneling or undermining was eradicated in 50% of PIs. The mean percent area reduction at the last recorded visit was 61% ± 30%. There were no postoperative complications.ConclusionThese results suggest that OFM-based grafts may serve as a valuable adjunct for the surgical management of late-stage PIs that are clinically challenging to heal.