Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ozonated product-based protocol for scar hygiene and care.
- Who it may be relevant to
- Registry conditions: Wound Healing, Abdominal Surgery, Scar Improvement. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Randomized, Evaluator-blinded Clinical Study to Compare a Post-surgical Scar Care Protocol Using OzoAqua Products Versus Standard Care in Open Abdominal Surgery.
Overview
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.
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 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.
Interventions
- Other Ozonated product-based protocol for scar hygiene and care
Ozonated oil soap and ozonated oil, added to standard postoperative care
Primary outcome measures
- Observer score on the POSAS scale at 3 months, using the linear version for surgical scars [Time frame: 3 months]
Secondary outcome measures (8)
- Patient score on the POSAS scale at 3 months [Time frame: 3 months]
- Observer score on the POSAS scale at 1 month [Time frame: 1 month]
- Patient score on the POSAS scale at 1 month [Time frame: 1 month]
- Surgical wound complications within the first month after the intervention [Time frame: 1 month]
- Scar pain measured using a visual analogue scale (VAS) at the 2-week, 1-month and 3-month visits [Time frame: 3 months]
- Scar pruritus measured using a numerical rating scale at the 2-week, 1-month and 3-month visits. [Time frame: 3 months]
- Patient global satisfaction with the scar, measured using a numerical rating scale at 3 months [Time frame: 3 months]
- Need for rescue scar treatment during the follow-up period [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Clínica Universidad de Navarra — Pamplona
Identifiers
NCT: NCT07678372 · OZOSCAR-CUN