Breast Surgery, Regeneration, Surgical Wound Healing
Conditions
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.
Detailed description
The study is conducted at Vinalopó University Hospital and Elche General University Hospital. 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 postoperative wounds in subjects undergoing unilateral breast surgery. The study hypothesis is that the investigational product improves and accelerates wound healing compared with a placebo product formulated with non-ozonated vegetable oils. The primary objective is to evaluate the regenerative and wound-healing efficacy of ozonated oil during the healing process of postoperative wounds, compared with a non-ozonated oil used as placebo. The specific objectives are to characterise the wound-healing progression pattern associated with both products, compare their quality and user experience, and correlate the quantitative data obtained using dermatological probes with the qualitative assessment of images of the treated areas. The study sample comprises 50 subjects, randomly assigned in a 1:1 ratio to two parallel groups. The control group includes 25 subjects who receive standard wound care with chlorhexidine and the placebo product, consisting of a blend of non-ozonated olive and sunflower oils. The experimental group includes a further 25 subjects who receive the same standard wound care with chlorhexidine and the investigational product, OZOAQUA MD OZONATED OIL. The randomisation sequence is generated using BlueSky Statistics software, version 10.3.2. A healthcare professional who is not involved in the clinical assessments records the correspondence between each participant and the assigned treatment in the randomisation list, thereby ensuring traceability and enabling its subsequent recording by the contract research organisation in each participant's case report form. The study is conducted under double-blind conditions, such that allocation to the active product or placebo remains concealed from both participants and the investigators responsible for the assessments. Following breast surgery, the wound is cleaned and disinfected according to standard practice, and the assigned product is applied in accordance with the randomisation sequence. The wound is subsequently covered with gauze or a dressing for the first 24-48 hours to reduce the risk of infection. After this period, participants continue to receive the necessary wound care in accordance with routine clinical practice, the duration of which depends on each patient's individual clinical course. The assigned product is applied for a fixed period of two months, once or twice daily, ensuring contact as close as possible to the sutures. A minimum interval of six hours must be maintained between applications, and no more than two applications may be performed per day. The study population comprises subjects aged between 25 and 75 years undergoing unilateral breast surgery. To participate, subjects must be in good general physical and psychological health, have voluntarily provided informed consent, and be willing to follow the product application instructions and attend the scheduled follow-up visits. The investigational product, OZOAQUA MD OZONATED OIL, is a class IIa medical device composed of a blend of ozonated olive and sunflower oils. It is administered topically and, after cleansing the area, is applied to the wound with a gentle massage to promote absorption. The placebo product consists of a blend of non-ozonated olive and sunflower oils. It is also administered topically and in accordance with the same application instructions as the investigational product, thereby supporting maintenance of blinding and allowing the effect specifically attributable to the ozonation process to be evaluated. Participants are assessed at four follow-up visits after surgery. The first visit takes place at Day 7 ± 1 and includes standardised image capture, scar assessment using the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale (POSAS), and collection of a dressing exudate sample for biomarker analysis. The second visit takes place at Day 15 ± 2 and includes image capture, assessment using the Vancouver Scar Scale and POSAS, and measurement of skin parameters using the Mexameter® and Cutometer®. These assessments are repeated approximately one month after surgery, within a ±2-day window, and again two months after surgery, also within a ±2-day window. Wound-healing progression is analysed using a combination of clinical, photographic, instrumental, and biological assessments. The variables include scar progression according to the Vancouver Scar Scale; patient and observer assessments using POSAS; changes in pigmentation and erythema measured using the Mexameter®; skin biomechanical properties and elasticity assessed using the Cutometer®; visual wound progression based on standardised images; and the user experience and quality of use of the products. Overall, the study aims to determine whether the topical application of OZOAQUA MD OZONATED OIL, as an adjunct to standard wound care with chlorhexidine, promotes faster or higher-quality wound healing than the use of a non-ozonated vegetable oil.
Interventions
DEVICEozonated oil
OZOAQUA MD Ozonated Oil + chlorhexidine
OTHERNon ozonated oil
Non ozonated oil + chlorhexidine
Sponsors
Laboratorios Ozoaqua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Vancouver Scar Scale (VSS) at 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Vancouver Scar Scale (VSS) at 7 days, 15 days and 1 month | 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 | 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 | 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. | 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. |
| Melanin index score measured using a Mexameter® at 15 days, 1 month, and 2 months. | 2 months | Melanin index provides an objective assessment of skin pigmentation by estimating the relative melanin content present in the skin and scar area. Monitoring this parameter over time allows changes in pigmentation associated with the wound-healing process to be assessed, including potential post-inflammatory hyperpigmentation or hypopigmentation. In general, higher values indicate a greater melanin content, whereas lower values reflect lower pigmentation in the assessed area. In the context of wound healing, this parameter should be interpreted taking into account its evolution over time, as marked variations from baseline values may be associated with pigmentation changes secondary to the tissue repair process. The results presented below allow the evolution of scar pigmentation to be assessed and the patterns observed between treatment groups to be compared throughout the study follow-up. |
| Objective assessment of the biomechanical properties of scar tissue using a Cutometer® at 15 days, 1 month, and 2 months. | 2 months | Cutometer® analyzes the R0 and R5 parameters, which are related to scar firmness and elasticity, respectively. In general, lower R0 values indicate greater tissue firmness, whereas higher R5 values reflect better elasticity and recovery capacity. These parameters provide complementary information on the scar maturation process and the functional evolution of the scar over the course of follow-up |
Countries
Spain
Contacts
CONTACTJuan Gabriel Agüera Santos
CONTACTLaura Caparrós Linares
Outcome results
None listed