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

NCT07809308 | Recruiting

• 1 other identifier: OZOAQUA - MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Surgery; Regeneration; Surgical Wound Healing

Outcome Measures

Primary Outcomes (1)

• Score on the Vancouver Scar Scale (VSS) at 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.

  2 months

Secondary Outcomes (6)

• Score on the Vancouver Scar Scale (VSS) at 7 days, 15 days and 1 month

  1 month

• Observer score on the Patient and Observer Scar Assessment Scale (POSAS) at 7 days, 15 days, 1 month, and 2 months

  2 months

• Patient score on the Patient and Observer Scar Assessment Scale (POSAS) at 7 days, 15 days, 1 month, and 2 months

  2 months

• Erythema index score measured using a Mexameter® at 15 days, 1 month, and 2 months.

  2 months

• Melanin index score measured using a Mexameter® at 15 days, 1 month, and 2 months.

  2 months

Other Outcomes (1)

• Adverse events during the follow-up period

  2 months

Study Arms (2)

OZOAQUA MD Ozonated Oil

EXPERIMENTAL

Standard wound care with chlorhexidine plus the investigational product (OZOAQUA MD Ozonated Oil)

Device: ozonated oil

Non-ozonated oil

PLACEBO COMPARATOR

Standard wound care with chlorhexidine plus the placebo product (non-ozonated oil)

Other: Non ozonated oil

Interventions

ozonated oil DEVICE

OZOAQUA MD Ozonated Oil + chlorhexidine

OZOAQUA MD Ozonated Oil

Non ozonated oil OTHER

Non ozonated oil + chlorhexidine

Non-ozonated oil

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Ozoaqua: lead

Study Sites (2)

Elche General University Hospital

Elche, Spain

RECRUITING

Vinalopó University Hospital, Elche

Elche, Spain

RECRUITING

Central Study Contacts

Juan Gabriel Agüera Santos

CONTACT

+34 623 02 25 86; juan.aguera@bioithas.com

Laura Caparrós Linares

CONTACT

laura.caparros@ozoaqua.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: February 6, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

ES (2)