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

NCT07678372 | Not Yet Recruiting

• 1 other identifier: OZOSCAR-CUN
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Surgery; Scar Improvement; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Observer score on the POSAS scale at 3 months, using the linear version for surgical scars

  The POSAS (Patient and Observer Scar Assessment Scale) is a validated scale used to assess scar quality from two complementary perspectives: that of the clinical observer and that of the patient. Only the clinical observer component of the POSAS scale will be assessed. This assessment will be performed by a blinded evaluator, who will be unaware of the patients' allocation to the treatment groups. The observer component of the POSAS scale, in its linear version for surgical scars, allows the quality of linear scars to be assessed through the clinical evaluation of parameters such as: * Vascularization * Pigmentation * Thickness * Relief * Pliability * Surface area Each parameter is scored from 1 to 10, where 1 corresponds to normal skin and 10 to the worst imaginable scar condition for that domain. The total observer score is obtained by summing the six items, resulting in a range of 6 to 60 points; lower scores indicate better scar quality.

  3 months

Secondary Outcomes (8)

• Patient score on the POSAS scale at 3 months

  3 months

• Observer score on the POSAS scale at 1 month

  1 month

• Patient score on the POSAS scale at 1 month

  1 month

• Surgical wound complications within the first month after the intervention

  1 month

• Scar pain measured using a visual analogue scale (VAS) at the 2-week, 1-month and 3-month visits

  3 months

Other Outcomes (3)

• Adverse events during the follow-up period

  3 months

• Treatment-related cutaneous adverse events during the follow-up period

  3 months

• Treatment adherence

  3 months

Study Arms (2)

Ozoaqua protocol treament + standard postoperative care

EXPERIMENTAL

Other: Ozonated product-based protocol for scar hygiene and care

Standard postoperative care

NO INTERVENTION

Physiological saline solution and aqueous chlorhexidine

Interventions

Ozonated product-based protocol for scar hygiene and care OTHER

Ozonated oil soap and ozonated oil, added to standard postoperative care

Ozoaqua protocol treament + standard postoperative care

Eligibility Criteria

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

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

Sponsors & Collaborators

• Laboratorios Ozoaqua: lead

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Central Study Contacts

Juan Gabriel Agüera Santos

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

ES (1)