Efficacy of a dermatological gel based on sunflower seed oil

Background

Bedsores, also known as pressure ulcers, are areas of damaged skin and underlying tissue that develop when sustained pressure - usually over bony areas such as the heels, hips or lower back - cuts off local blood supply. They are common among patients who are bedridden or have limited mobility, including those cared for at home rather than in hospital. Standard care typically involves regular dressing changes, pressure relief and topical treatments, but healing can be slow, and clinicians continue to look for products that combine antimicrobial action with tissue-repair support. Ozonised (ozonated) sunflower oil has been investigated in other skin conditions for its antimicrobial and wound-healing properties, and this study examined whether a gel formulated from it - referred to by the researchers as Oz.Or.Oil 30 - could improve outcomes specifically in bedsores.

Study design

Researchers based in Italy ran a randomised, single-blind pilot study on patients receiving hospital-at-home care between September 2016 and March 2017. Twenty-two patients with stage I or stage II bedsores were enrolled; nineteen completed the study, as three discontinued participation. Participants were randomly assigned on a 1:1 basis to an experimental group (11 patients), who applied the ozonised sunflower oil gel twice daily, or a control group (8 patients), who used a standard dermatological gel over the same period. Treatment continued for 21 days, with weekly clinical assessments and photographic documentation used to score wound healing at each check-in.

Findings

By the second week of treatment, the group using the ozonised oil gel showed significantly higher healing scores than the control group (1.00 ± 0.00 versus 0.45 ± 0.52, p=0.014), indicating faster improvement in the ulcers. The trend towards better outcomes with the ozonised gel continued through the remainder of the 21-day observation period.

What the authors concluded

The authors concluded that Oz.Or.Oil 30 could be considered an effective treatment for bedsores, proposing that ozone's antimicrobial action and its capacity to stimulate tissue repair were the likely mechanisms behind the faster healing observed. They noted this was a preliminary result and called for further research with larger patient numbers.

Limitations of this study

This was a small pilot study - only 19 patients completed it, split across two small groups (11 and 8), which limits how confidently the results can be generalised. Three enrolled patients discontinued before completion, and the reasons for this were not fully explored in relation to the outcomes. The single-blind design means only participants (not assessors or treating staff) may have been unaware of group allocation, leaving room for observer bias in the weekly scoring. The study was conducted at a single hospital-at-home service in Italy over a relatively short 21-day period, so longer-term healing, recurrence and safety data are not available. As the authors themselves acknowledged, larger, more rigorously controlled studies are needed before firm conclusions can be drawn about the gel's effectiveness for bedsores.