Topical Wound Oxygen (two₂™) Versus Conventional Compression Dressings in the Management of Refractory Non-healing Venous Ulcers; A Parallel Observational Pivotal Study

Wael Tawfick', Sherif Sultan
Western Vascular Institute, Department of Vascular & Endovascular Surgery,
University College Hospital, Galway,  
The Galway Clinic, Doughiska, Dublin Road Galway,
Ireland
 
Royal Academy of Medicine in Ireland, Irish Journal of Medical Science,
Volume 176, Number 1, 2007 Supplement 2, 5th Annual Vascular Institute
Symposium, Galway

Venous ulceration is a common ailment with an incidence of 3 per 1000 population and 20 per 1000 population in Octogenarians. The cost of managing venous ulcers amasses to 1.6 Billion Euros per year. The aim of this study is to prove the safety and efficacy of topical wound oxygen (two₂™) in managing refractory venous ulcers.
 
Our primary end point is the proportion of ulcers healed, percentage reduction in the ulcer size, time taken for full healing or for the ulcer to be ready for skin grafting, degree of bacterial elimination at end of therapy and absence of scarring and reverse gradient phenomenon. Our secondary end points are quality of life, pain reduction and recurrence rates. Leg ulcers were digitally photographed and swabbed. The ulcer was measured using Visitrak to determine surface area, maximum width, length and depth of the ulcer. Punch biopsies were taken from all ulcers. Necrotic tissue was debrided after 72 hours of treatment. In the two₂™ group the limb was placed in the chamber for 180 minutes twice daily under pressure of 50 mbars, with oxygen supplied at 10 litres/minute. The compression group were managed using Profore compression dressings with underlying low-adherent dressings. Ulcers were digitally photographed and measured at 3 day intervals and swabbed weekly.