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

Sponsor: Laboratorios Ozoaqua • ClinicalTrials.gov ID: NCT07809308

Registry updated: 2026-09-09

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Description

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.

Interventions

ozonated oil (Device)
OZOAQUA MD Ozonated Oil + chlorhexidine
Non ozonated oil (Other)
Non ozonated oil + chlorhexidine

Eligibility criteria

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

Conditions

Breast Surgery Regeneration Surgical Wound Healing

Locations

Elche General University Hospital — Elche, Spain
Vinalopó University Hospital, Elche — Elche, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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