Non ozonated oil: Non ozonated oil + chlorhexidine
Study summary
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 surgical wounds in patients undergoing breast surgery.
The study includes 50 participants, randomly assigned in a 1:1 ratio to two treatment groups. The primary objective is to determine whether ozonated oil improves and accelerates postoperative wound healing compared with placebo. Additional objectives include characterising the course of wound healing, comparing the user experience associated with both products, and correlating clinical and photographic assessments with instrumental measurements obtained using dermatological probes.
Follow-up assessments are performed approximately 7, 15, 30, and 60 days after surgery. Evaluations include standardised image capture, scar assessment using the Vancouver Scar Scale and POSAS, and measurement of skin parameters using the Mexameter® and Cutometer®.
The study is conducted at Vinalopó University Hospital and Elche General University Hospital.
Eligibility
Sex
ALL
Min age
25 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Score on the Vancouver Scar Scale (VSS) at 2 months — 2 months The Vancouver Scar Scale (VSS) is a clinician-rated scale used to assess scar characteristics. It evaluates four domains: vascularity, pigmentation, pliability, and scar height. Each domain is scored using predefined ordinal categories, and the individual scores are summed to obtain a total score ranging from 0 to 13, with higher scores indicating greater scar severity.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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