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

RecruitingNAAges 25 Years - 75 YearsAllLaboratorios Ozoaqua
NCT07809308 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Van

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📋 Eligibility rules (as published)
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
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What it tests

  • ozonated oil
  • Non ozonated oil
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Where

2 sites
Elche General University Hospital
Elche, Spain
Vinalopó University Hospital, Elche
Elche, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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