Protocol for a randomized controlled trial of transdermal continuous oxygen therapy for surgical site wound healing after lower extremity revascularization

<h2>Abstract</h2><h3>Objective</h3> Patients undergoing vascular surgery are at increased risk of poor wound healing due to ischemia and their underlying comorbidities. Following lower extremity revascularization, 40% to 50% of patients experience non-healing wounds that persist for months despite functional bypass grafts. Additionally, surgical site infections (SSIs) in these patients can lead to sepsis, disability, and limb loss. SSI rates are reported between 5% and 10% and as high as 32% for infrainguinal incisions. Supplemental systemic oxygen therapy has shown promise in improving wound healing and reducing SSIs. An emerging alternative is transdermal continuous oxygen therapy (TCOT), which delivers oxygen directly to the wound, thereby avoiding systemic effects of oxygen and simplifying the logistics of oxygen delivery. TCOT has demonstrated faster wound healing and lower infection rates compared with standard of care wound therapy in preliminary studies. We propose a randomized trial to provide level one evidence on the effectiveness of TCOT in improving incisional healing and reducing SSI rates in vascular surgery patients. <h3>Methods</h3> This randomized controlled trial will enroll 100 participants aged 18 to 90 years undergoing elective lower extremity arterial revascularization at the University of Maryland Medical Center and Baltimore VA Medical Center. Participants will be randomized 1:1 to receive either TCOT with control dressing, or control dressing alone. The investigational device, EPIFLO, will be used to deliver continuous oxygen to the wound via a semi-occlusive dressing for up to 28 days. The primary endpoint is the percent wound closure rate at 4 weeks, assessed using the Bates-Jensen Wound Assessment Tool. The secondary endpoint is SSI incidence at 90 days, evaluated with the Szilagyi classification. Participants will attend five follow-up visits, during which wound healing, SSIs, and adverse events will be recorded. A centralized randomization system will ensure balanced allocation, and blinded evaluators will assess wound images to reduce bias. Statistical analysis will include mixed models for repeated measures and Barnard's test for SSI rates. <h3>Conclusions</h3> This study will provide level one evidence on the efficacy of TCOT in improving wound healing and preventing SSIs in vascular surgery patients.