Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care

The study follow-up will be integrated into the usual care pathway, with a preoperative phase, an in-hospital phase during the immediate postoperative period, and three subsequent outpatient visits.

At the preoperative visit, the patient will be informed about the study and informed consent will be obtained. In addition, baseline data will be collected, potential risk factors for poor wound healing will be identified, and the scheduled open abdominal surgery will be confirmed.

During the immediate postoperative period and hospital stay, approximately between Day 0 and Day 3, the patient's final eligibility will be confirmed, randomization will be performed, and the assigned treatment will be initiated. During this phase, a daily clinical assessment of the surgical wound will be carried out, recording dressing status, presence of exudate, wound edge approximation, erythema, inflammation, pain, temperature, drainage if applicable, wound care procedures performed, local tolerability and incidents. Definitive surgical data will also be documented, including incision type, scar length and closure type.

At the 2-week visit, with a ±5-day window, the wound or scar will be examined, potential complications will be recorded, skin safety and treatment adherence will be assessed, and pain and pruritus will be evaluated. A standardized photograph will also be obtained.

At the 1-month visit, with a ±7-day window, the clinical evolution of the scar will be assessed. If the scar is assessable, the POSAS scale will be administered. Pain, pruritus, adherence and skin safety will also be recorded, and standardized photography will be repeated.

The 3-month visit, with a ±14-day window, will be the main study visit. At this visit, efficacy will be assessed using the POSAS scale from the patient's perspective and by the blinded observer. Pain, pruritus, overall satisfaction with the scar, final standardized photography, rescue treatments and adverse events will also be recorded.

The Ozoaqua intervention will consist of a specific scar hygiene and care protocol using Ozoaqua ozonated oil soap and Ozoaqua ozonated oil, added to standard postoperative care. During the first 48-72 hours, no non-prescribed topical products will be initiated (do not use ozonated oil soap or ozonated oil during this phase), prioritizing keeping the wound dry, clinical monitoring and routine hospital wound care. Ozonated oil soap may be started approximately from 72 hours or after dressing removal, provided that the wound is closed, without exudate, without signs of infection, and with intact sutures or staples. Home application will include hygiene with lukewarm water and ozonated oil soap, gentle drying without friction, and application of a thin layer of oil to clean, dry skin, with a maximum of two applications per day separated by at least 6 hours.

The planned sample size is 144 patients, 72 per arm, assuming a 10% dropout rate.

• Patient score on the POSAS scale at 3 months [Срок оценки: 3 months]
• Observer score on the POSAS scale at 1 month [Срок оценки: 1 month]
• Patient score on the POSAS scale at 1 month [Срок оценки: 1 month]
• Surgical wound complications within the first month after the intervention [Срок оценки: 1 month]
• Scar pain measured using a visual analogue scale (VAS) at the 2-week, 1-month and 3-month visits [Срок оценки: 3 months]
• Scar pruritus measured using a numerical rating scale at the 2-week, 1-month and 3-month visits. [Срок оценки: 3 months]
• Patient global satisfaction with the scar, measured using a numerical rating scale at 3 months [Срок оценки: 3 months]
• Need for rescue scar treatment during the follow-up period [Срок оценки: 3 months]