Is topical Ozone therapy effective in healing of chronic wounds compared to sham procedure?

The study setting includes the professorial surgical wards and surgical clinics of Teaching Hospital Anuradhapura. Participants will be patients aged 18 or over with chronic wounds, who have not received topical Ozone therapy previously.

Method of randomization includes a covariates adaptive randomization based on age and gender. The randomization will done via computer generated programme which takes in to account the above parameters.

Intervention: The EXT 120 Ozone Generator will be used to generate the ozone/oxygen mixture at differing concentrations as required. The wound will be cleaned initially with the ozonized water (produced by the EXT 120 Ozone generator). A bag will be placed over and around the chronic wound and the gas of Ozone/Oxygen mixture of differing concentrations generated by the Ozone generator will be used to fill the bag surrounding the chronic wound and continued for 30 minutes.

The ozone/oxygen mixture is initially applied at higher concentrations (96% oxygen and 4% (80 µg/ml) Ozone) three times a week until the wound size is reduced by 50% or a maximum of four weeks. Then the dose is decreased to a lower concentration (98% oxygen and 2% (40 µg/ml) Ozone) and applied twice a week for another 4 weeks. Finally, the ozone concentration will be reduced to 99% oxygen and 1% (20 µg/ml) Ozone and applied twice a week for another 4 weeks. The total period of intervention for a patient will be 12 weeks. Standard of care for chronic wounds consists of cleaning, dressing, and in some cases debridement of the wound. It further includes swabbing for identification of infection and use of antibiotics if indicated.

Control: The procedure for the control arm participants will be that the EXT 120 Ozone Generator is set to the inactive mode and room air delivered in the same manner. Treatment frequency will be the same. Control arm participants will also receive the standard wound care as usual.

Males and females who are 18 years or older with chronic wounds (wounds that fail to proceed through the normal phases of wound healing in an orderly and timely manner).

• Patients with known contraindication to ozone therapy • Any patient who had previously been treated with ozone or hyperbaric oxygen therapy, • A history of collagen disease, • Pregnant mothers. • Participants with cognitive impairment (patients with psychotic illnesses, learning disability).