Abstract
Pressure ulcers remain a major cause of morbidity in skilled nursing facility populations, where frailty and comorbid conditions hinder healing. Numerous studies have established Nitric oxide's role in tissue repair, angiogenesis, and infection control, suggesting therapeutic potential for nitric oxide in chronic wound healing. A retrospective observational cohort study was conducted using de-identified data from skilled nursing patients presenting with pressure ulcers. Two matched cohorts (200 patients per group) were compared: Those treated with a nitric oxide-delivering foam and historical controls receiving standard of care. Propensity score matching accounted for baseline wound size, stage, sex, comorbidities, and treatment start date. The primary endpoint was complete closure (epithelialized or had an area of zero) within 12 weeks. Bayesian hierarchical hurdle-gamma regression estimated treatment effects using posterior means and 95% credible intervals. Within 12 weeks, closure or resolution rates had a significant benefit in the treatment group across most stages: 94% versus 79% for Stage 1, 80% versus 45% in Stage 2, 64% versus 28% in Stage 3, 39% versus 12% in unstageable, 34% versus 10% in Stage 4, and 67% versus 31% for Deep Tissue Pressure Injuries. Overall, 63% (95% CrI 50%-75%) of NODF-treated wounds healed compared with 34% (21%-47%) of SOC wounds. Posterior probabilities of superior healing with NODF exceeded 99% for most comparisons.