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

Prospective, Randomized, Evaluator-blinded Clinical Study to Compare a Post-surgical Scar Care Protocol Using OzoAqua Products Versus Standard Care in Open Abdominal Surgery.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing; Post-surgical Abdominal Scar After Open Abdominal Surgery
• Intervention / Treatment: Other: Ozonated product-based protocol for scar hygiene and care

Detailed Description

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 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 soap or ozonated oil during this phase), prioritizing keeping the wound dry, clinical monitoring and routine hospital wound care. Ozonated 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Gabriel Agüera Santos; Phone Number: +34 623 02 25 86; Email: juan.aguera@bioithas.com

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clínica Universidad de Navarra
      • Contact: Nuria Pretel Garrido; Phone Number: +34 658 34 59 91; Email: npretelgar@unav.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozoaqua protocol treament + standard postoperative care	Other: Ozonated product-based protocol for scar hygiene and care; Ozonated oil soap and ozonated oil, added to standard postoperative care
No Intervention: Standard postoperative care; Physiological saline solution and aqueous chlorhexidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient score on the POSAS scale at 3 months	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 patient component of the POSAS scale will be assessed. This assessment will be completed by the patient, reflecting her own perception of the scar and associated symptoms. The patient component of the POSAS scale, allows scar quality to be assessed from the patient's perspective through the evaluation of parameters such as: Pain Pruritus Color Stiffness Thickness Irregularity Each parameter is scored from 1 to 10, where 1 corresponds to normal skin or absence of symptoms and 10 to the worst imaginable scar condition or symptom intensity for that domain. The total patient score is obtained by summing the six items, resulting in a range of 6 to 60 points; lower scores indicate better perceived scar quality.	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	Surgical wound complications within the first 30 postoperative days, defined as the occurrence of any local event related to the abdominal incision, including infection, partial or complete dehiscence, seroma, hematoma, persistent exudate, or the need for additional wound care procedures/interventions.	1 month
Scar pain measured using a visual analogue scale (VAS) at the 2-week, 1-month and 3-month visits	Scar-related pain will be assessed using a visual analogue scale from 0 to 10 at the 2-week, 1-month and 3-month follow-up visits, where 0 indicates no pain and 10 indicates the worst imaginable pain.	3 months
Scar pruritus measured using a numerical rating scale at the 2-week, 1-month and 3-month visits.	Scar-related pruritus will be assessed using a 0-10 numerical rating scale, where 0 indicates no pruritus and 10 indicates the worst imaginable pruritus.	3 months
Patient global satisfaction with the scar, measured using a numerical rating scale at 3 months	Global satisfaction with the scar will be assessed by the patient using a 0-10 numerical rating scale, where 0 indicates no satisfaction at all and 10 indicates maximum satisfaction with the scar outcome	3 months
Need for rescue scar treatment during the follow-up period	The need to initiate any additional treatment not planned in the protocol, indicated according to clinical judgment, for the management of unfavorable scar evolution or wound/scar-related complications will be recorded	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related cutaneous adverse events during the follow-up period	The occurrence of any undesirable cutaneous event in the application area or perilesional area during the treatment and follow-up period will be recorded, regardless of its causal relationship with the products used. These events may include irritation, erythema, stinging, burning sensation, pruritus, dryness, contact dermatitis, local allergic reaction, desquamation, local pain, or any other clinically relevant cutaneous reaction.	3 months

Collaborators and Investigators

• Sponsor: Laboratorios Ozoaqua

Study record dates

Study Major Dates

• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OZOSCAR-CUN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No