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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.
Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.
The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.
Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.
ClinicalTrials.gov Registry NCT04889417.
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