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

Starting soon · Not applicable

Conditions studied: Wound Healing, Abdominal Surgery, Scar Improvement

In brief

A prospective, randomized clinical study with a blinded evaluator to compare a post-surgical abdominal scar care protocol using Ozoaqua products versus standard care in patients undergoing open abdominal surgery. The primary objective is to assess whether the use of Ozoaqua, initiated in the immediate postoperative period according to wound evolution, improves abdominal scar quality at 3 months compared with usual care. The proposed design is an initial single-center study at the Clínica Universidad de Navarra, with 1:1 random allocation to two parallel arms: an intervention group receiving standard care plus Ozoaqua ozonated soap and oil, and a control group receiving standard care only. The primary scar assessment will be performed by a blinded evaluator, while treatment will be open-label due to the nature of the topical intervention. The target population consists of adult patients undergoing scheduled open abdominal surgery, with primary wound closure and an assessable linear abdominal scar. Follow-up will be integrated into routine clinical care, including an in-hospital phase during the first postoperative days and outpatient visits at approximately 2 weeks, 1 month and 3 months, with the latter being the main study visit. The primary endpoint will be scar quality at 3 months, assessed using the POSAS scale, particularly the blinded observer score. Secondary endpoints will include the patient POSAS score, scar evolution, wound complications, pain, pruritus, satisfaction, cutaneous adverse events, rescue treatments and adherence.

Key facts

Study ID

NCT07678372

Run by

Laboratorios Ozoaqua

People needed

144

Starts

2026-07-06

Expected to finish

2027-07-06

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Scheduled open abdominal surgery
• Primary wound closure
• Assessable linear abdominal scar
• Signed informed consent
• Ability to complete 3-month follow-up

You may not qualify if…

• Known allergy to treatment components
• Active infection or significant dehiscence in the immediate postoperative period
• Planned use of specific scar treatments -silicone products, laser therapy, local corticosteroids- except as clinical rescue treatment
• Inability to complete follow-up
• Participation in another study that may interfere with wound healing

Where it is running

• Clínica Universidad de Navarra — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

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