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 University Hospital.

This is a multicentre, prospective, randomised, double-blind, placebo-controlled clinical study designed to evaluate the regenerative and wound-healing efficacy of OZOAQUA MD OZONATED OIL in postoperative wounds in subjects undergoing unilateral breast surgery. The study hypothesis is that the investigational product improves and accelerates wound healing compared with a placebo product formulated with non-ozonated vegetable oils.

The primary objective is to evaluate the regenerative and wound-healing efficacy of ozonated oil during the healing process of postoperative wounds, compared with a non-ozonated oil used as placebo. The specific objectives are to characterise the wound-healing progression pattern associated with both products, compare their quality and user experience, and correlate the quantitative data obtained using dermatological probes 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 parallel groups. The control group includes 25 subjects who receive standard wound care with chlorhexidine and the placebo product, consisting of a blend of non-ozonated olive and sunflower oils. The experimental group includes a further 25 subjects who receive the same standard wound care with chlorhexidine and the investigational product, OZOAQUA MD OZONATED OIL. The randomisation sequence is generated using BlueSky Statistics software, version 10.3.2. A healthcare professional who is not involved in the clinical assessments records the correspondence between each participant and the assigned treatment in the randomisation list, thereby ensuring traceability and enabling its subsequent recording by the contract research organisation in each participant's case report form. The study is conducted under double-blind conditions, such that allocation to the active product or placebo remains concealed from both participants and the investigators responsible for the assessments.

Following breast surgery, the wound is cleaned and disinfected according to standard practice, and the assigned product is applied in accordance with the randomisation sequence. The wound is subsequently covered with gauze or a dressing for the first 24-48 hours to reduce the risk of infection. After this period, participants continue to receive the necessary wound care in accordance with routine clinical practice, the duration of which depends on each patient's individual clinical course. The assigned product is applied for a fixed period of two months, once or twice daily, ensuring contact as close as possible to the sutures. A minimum interval of six hours must be maintained between applications, and no more than two applications may be performed per day.

The study population comprises subjects aged between 25 and 75 years undergoing unilateral breast surgery. To participate, subjects must be in good general physical and psychological health, have voluntarily provided informed consent, and be willing to follow the product application instructions and attend the scheduled follow-up visits.

The investigational product, OZOAQUA MD OZONATED OIL, is a class IIa medical device composed of a blend of ozonated olive and sunflower oils. It is administered topically and, after cleansing the area, is applied to the wound with a gentle massage to promote absorption.

The placebo product consists of a blend of non-ozonated olive and sunflower oils. It is also administered topically and in accordance with the same application instructions as the investigational product, thereby supporting maintenance of blinding and allowing the effect specifically attributable to the ozonation process to be evaluated.

Participants are assessed at four follow-up visits after surgery. The first visit takes place at Day 7 ± 1 and includes standardised image capture, scar assessment using the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale (POSAS), and collection of a dressing exudate sample for biomarker analysis. The second visit takes place at Day 15 ± 2 and includes image capture, assessment using the Vancouver Scar Scale and POSAS, and measurement of skin parameters using the Mexameter® and Cutometer®. These assessments 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 progression according to the Vancouver Scar Scale; patient and observer assessments using POSAS; changes in pigmentation and erythema measured using the Mexameter®; skin biomechanical properties and elasticity assessed using the Cutometer®; visual wound progression based on 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 MD OZONATED OIL, as an adjunct to standard wound care with chlorhexidine, promotes faster or higher-quality wound healing than the use of a non-ozonated vegetable oil.

Inclusion criteria

• Subjects aged between 25 and 75 years at the time of signing the informed consent form.
• Subjects undergoing unilateral breast surgery.
• Subjects in good physical and psychological health.
• Subjects who have voluntarily provided written informed consent, either personally or, where applicable, through a family member, custodian, or legal representative.
• Subjects willing to comply with the study procedures, including the instructions for use of the assigned product and attendance at the scheduled follow-up visits.

Exclusion criteria

• Pregnant or breastfeeding women.
• Subjects with a history of chronic or currently active skin disease that, in the investigator's opinion, may adversely affect dermal regeneration.
• Subjects with diseases or disorders that, in the investigator's opinion, could interfere with the assessment of safety or effectiveness.
• Subjects with any acute infectious disease.
• Subjects with any systemic disease that could worsen the prognosis in the event of an adverse event, including poorly controlled diabetes with retinopathy or peripheral vascular disease, severe hypertension, or other serious disease.
• Subjects who are members of the study team, including investigators, collaborators, nursing staff, site employees, or any other person directly involved in the conduct of the protocol.
• Subjects with a skin phototype greater than V