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.
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.
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.
Parallel
ozonated oil
DeviceOZOAQUA MD Ozonated Oil + chlorhexidine
Non ozonated oil
Other interventionNon ozonated oil + chlorhexidine
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.
Score on the Vancouver Scar Scale (VSS) at 7 days, 15 days and 1 month
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.
Observer score on the Patient and Observer Scar Assessment Scale (POSAS) at 7 days, 15 days, 1 month, and 2 months
The Patient and Observer Scar Assessment Scale (POSAS) is a validated scar assessment tool that combines evaluations from both the clinician and the patient. It consists of two complementary components: the Observer Scale and the Patient Scale. Both components assess different characteristics of the scar using 10-point numerical rating scales, where a score of 1 represents characteristics comparable to normal skin and a score of 10 represents the worst imaginable scar condition. Higher scores therefore indicate greater scar severity The POSAS Observer Scale is completed by a trained clinician or investigator. It evaluates six scar characteristics: vascularity, pigmentation, thickness, relief, pliability, and surface area. Each item is scored from 1 to 10. The six item scores are summed to obtain a total Observer Scale score ranging from 6 to 60, with higher scores indicating greater scar severity
Patient score on the Patient and Observer Scar Assessment Scale (POSAS) at 7 days, 15 days, 1 month, and 2 months
The Patient and Observer Scar Assessment Scale (POSAS) is a validated scar assessment tool that combines evaluations from both the clinician and the patient. It consists of two complementary components: the Observer Scale and the Patient Scale. Both components assess different characteristics of the scar using 10-point numerical rating scales, where a score of 1 represents characteristics comparable to normal skin and a score of 10 represents the worst imaginable scar condition. Higher scores therefore indicate greater scar severity The POSAS Patient Scale is completed by the patient and assesses six scar-related characteristics: pain, itching, color, stiffness, thickness, and irregularity. Each item is scored from 1 to 10, with higher scores indicating greater symptom burden or greater deviation from normal skin. The six item scores are summed to obtain a total Patient Scale score ranging from 6 to 60
Erythema index score measured using a Mexameter® at 15 days, 1 month, and 2 months.
The erythema index measured using a Mexameter® provides an objective assessment of the degree of redness of the skin and scar. This parameter is related to the vascularization and local inflammatory response present during the wound-healing process. In general, higher values indicate a greater degree of erythema, whereas lower values reflect reduced redness and a more favorable progression toward scar maturation. Therefore, monitoring this parameter over time allows the evolution of the scar to be objectively assessed and the response observed between the different study groups to be compared.
Adverse events during the follow-up period
Adverse events will be recorded throughout the follow-up period, including their severity and relationship to the study treatment
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