Efficacy of a Dermatological Gel Based on Ozonized Sunflower Seed Oil (Oz.Or.Oil 30) on Bedsores: A Pilot Study

Objective: The purpose of this pilot study was to evaluate the efficacy of topical applications of a dermatological gel based on ozonized sunflower seed oil (Oz.Or.Oil 30) on bedsores of patients admitted to the “hospital-at-home” service of the Hospital “Veris Delli Ponti” in Scorrano (Lecce, Italy). Methods: Study was made up of all patients with bedsores at stage I and II admitted to the “hospital-at-home” between September 2016 and March 2017. This pilot study was performed in randomized single blind with randomization in parallel 1:1 ratio. Sample of 22 patients was eligible, according to inclusion and exclusion criteria. They were divided into 2 groups: the experimental group treated with Oz.Or.Oil 30 and the control group treated with a common dermatological gel. To evaluate the tissue repair process, the observation period was 21 days and weekly evaluations to analyze ulcer more regularly, detect complications as soon as possible and adapt the treatment plan accordingly. Results: 19 patients completed the study because 3 patients discontinued study participation. Every patient reported regularly for the follow-up and reported no side effects. From the evaluation score of the analyzed patients, in the observation period, it shows that the patients treated with Oz.Or.Oil 30 showed faster healing of the ulcer. In the second week, patients treated showed significant improvement (p<0.05) compared to the control group, with efficacy scores equal to 1.00 ± 0.00 and 0.45 ± 0.52 respectively (p=0.014). Conclusion: Oz.Or.Oil 30 showed a much better efficacy than the control product, probably due to the high antibacterial and germicidal power of ozone and its capacity to stimulate tissue reparation. All patients were satisfied with the treatment whether they were in one group or the other. Further detailed studies are required with larger samples, but this study demonstrated that Oz.Or.Oil 30 can be considered as an effective medication in the treatment of bedsores.