Clinical Investigation of an Ozonated Oil for the Regeneration and Healing of Surgical Wounds in Patients Undergoing Breast Surgery

The study is conducted at Vinalopó University Hospital and Elche General UniversityHospital.This is a multicentre, prospective, randomised, double‐blind, placebo‐controlled clinicalstudy designed to evaluate the regenerative and wound‐healing efficacy of OZOAQUA MDOZONATED OIL in postoperative wounds in subjects undergoing unilateral breast surgery.The study hypothesis is that the investigational product improves and accelerates woundhealing compared with a placebo product formulated with non‐ozonated vegetable oils.The primary objective is to evaluate the regenerative and wound‐healing efficacy ofozonated oil during the healing process of postoperative wounds, compared with anon‐ozonated oil used as placebo. The specific objectives are to characterise thewound‐healing progression pattern associated with both products, compare their qualityand user experience, and correlate the quantitative data obtained using dermatologicalprobes with the qualitative assessment of images of the treated areas.The study sample comprises 50 subjects, randomly assigned in a 1:1 ratio to two parallelgroups. The control group includes 25 subjects who receive standard wound care withchlorhexidine and the placebo product, consisting of a blend of non‐ozonated olive andsunflower oils. The experimental group includes a further 25 subjects who receive thesame standard wound care with chlorhexidine and the investigational product, OZOAQUA MDOZONATED OIL. The randomisation sequence is generated using BlueSky Statistics software,version 10.3.2. A healthcare professional who is not involved in the clinical assessmentsrecords the correspondence between each participant and the assigned treatment in therandomisation list, thereby ensuring traceability and enabling its subsequent recordingby the contract research organisation in each participant's case report form. The studyis conducted under double‐blind conditions, such that allocation to the active product orplacebo remains concealed from both participants and the investigators responsible forthe assessments.Following breast surgery, the wound is cleaned and disinfected according to standardpractice, and the assigned product is applied in accordance with the randomisationsequence. The wound is subsequently covered with gauze or a dressing for the first 24‐48hours to reduce the risk of infection. After this period, participants continue toreceive the necessary wound care in accordance with routine clinical practice, theduration of which depends on each patient's individual clinical course. The assignedproduct is applied for a fixed period of two months, once or twice daily, ensuringcontact as close as possible to the sutures. A minimum interval of six hours must bemaintained between applications, and no more than two applications may be performed perday.The study population comprises subjects aged between 25 and 75 years undergoingunilateral breast surgery. To participate, subjects must be in good general physical andpsychological health, have voluntarily provided informed consent, and be willing tofollow the product application instructions and attend the scheduled follow‐up visits.The investigational product, OZOAQUA MD OZONATED OIL, is a class IIa medical devicecomposed of a blend of ozonated olive and sunflower oils. It is administered topicallyand, after cleansing the area, is applied to the wound with a gentle massage to promoteabsorption.The placebo product consists of a blend of non‐ozonated olive and sunflower oils. It isalso administered topically and in accordance with the same application instructions asthe investigational product, thereby supporting maintenance of blinding and allowing theeffect specifically attributable to the ozonation process to be evaluated.Participants are assessed at four follow‐up visits after surgery. The first visit takesplace at Day 7 ± 1 and includes standardised image capture, scar assessment using theVancouver Scar Scale and the Patient and Observer Scar Assessment Scale (POSAS), andcollection of a dressing exudate sample for biomarker analysis. The second visit takesplace at Day 15 ± 2 and includes image capture, assessment using the Vancouver Scar Scaleand POSAS, and measurement of skin parameters using the Mexameter® and Cutometer®. Theseassessments are repeated approximately one month after surgery, within a ±2‐day window,and again two months after surgery, also within a ±2‐day window.Wound‐healing progression is analysed using a combination of clinical, photographic,instrumental, and biological assessments. The variables include scar progressionaccording to the Vancouver Scar Scale; patient and observer assessments using POSAS;changes in pigmentation and erythema measured using the Mexameter®; skin biomechanicalproperties and elasticity assessed using the Cutometer®; visual wound progression basedon standardised images; and the user experience and quality of use of the products.Overall, the study aims to determine whether the topical application of OZOAQUA MDOZONATED OIL, as an adjunct to standard wound care with chlorhexidine, promotes faster orhigher‐quality wound healing than the use of a non‐ozonated vegetable oil.