Ozonated oil to help healing after breast surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial randomly assigns 50 adults undergoing unilateral breast surgery to receive either ozonated oil or a placebo oil, both with standard wound care, to see if the ozonated product improves healing. It is prospective, double-blind, and placebo-controlled, with follow-ups around days 7, 15, 30, and 60. Wound healing is evaluated with clinical assessments, photographs, and skin measurements using dermatology probes to correlate objective data with visual outcomes. The study is conducted at Elche General University Hospital and Vinalopó University Hospital, sponsored by Laboratorios Ozoaqua.

Why it matters

Who can join: the full rules

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

Where it's running

• Elche General University Hospital
  Elche, Spain Recruiting
• Vinalopó University Hospital, Elche
  Elche, Spain Recruiting

Study contacts

• Study coordinator: Juan Gabriel Agüera Santos
• Email: juan.aguera@bioithas.com
• Phone: +34 623 02 25 86

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.