Real-world analysis of the effect of adjunctive Vaporous Hyperoxia Therapy on the healing of chronic wounds

Introduction: Vaporous hyperoxia therapy (VHT) is a FDA-510(k) cleared technology  used adjunctively with standard wound care. VHT administers a low-frequency, noncontact, nonthermal ultrasonic mist with topical oxygen therapy. A retrospective analysis of patients with chronic wounds evaluated the healing effect of­­ VHT.Methods:We reviewed data of patients with chronic wounds (≥4 weeks) treated with VHT at 10 clinics from February 6, 2020, through August 30, 2022. After debridement (as appropriate), the affected limb was placed in the treatment basin, and a 56-minute treatment of alternating cycles of ultrasonic mist and TOT was administered. Wounds were offloaded and dressed appropriately.  Twice-weekly treatments occurred until the wound healed (complete epithelialization and granulation). The number of wounds healed at 16 weeks and the percentage area and volume reduction were analyzed. A Kaplan-Meier healing analysis determined time to heal.Results:Data from 249 patients were reviewed; 40 (17%) patients with 53 wounds were eligible and included. Most patients were male (n = 26, 65%) and aged 65-74 years (n = 21, 53%). The mean [standard deviation (SD)] comorbidity count per patient was 4.6 (2.5). The wounds were predominantly DFUs (n = 47; 88%); 72% (n = 38) of these were Wagner 2 ulcers. Five patients were treated with VHT in combination with ≤5 cellular and/or tissue-based products (CTPs). The median (interquartile range) wound duration was 2.0 months (3.0). The median baseline wound area was 1.5 cm2 (3.9). The median number of treatments was 18 (21); the median treatment length was 60 days (76.5). At 16 weeks, 41 (76%) wounds healed, including all 5 wounds treated with VHT and CTPs. The mean healing time was 14.5 weeks (95% Confidence Interval: 9.9-18.1). The respective mean percentage area and volume reduction over 16 weeks were 69% (156.7) and 82% (70.3)Discussion: This real-world analysis of patients with multimorbidities demonstrates that VHT healed most chronic wounds within 14 weeks. The hypersaturation and oxygenation of the wound tissue stimulate angiogenesis, reduce bioburden, and accelerate granulation tissue formation. VHT also appears to accelerate healing in wounds that are also treated with CTPs, but this finding warrants further investigation.References: