Wound HealingNCT07678372
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
A study testing Ozonated product-based protocol for scar hygiene and care in people with Wound Healing and Abdominal Surgery, run by Laboratorios Ozoaqua at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound Healing, Abdominal Surgery, Scar Improvement
- What is being tested?
- Ozonated product-based protocol for scar hygiene and care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Aug 2026to 6 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Scheduled open abdominal surgery
- Primary wound closure
- Assessable linear abdominal scar
- Signed informed consent
- Ability to complete 3-month follow-up
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clínica Universidad de Navarra, sede Madrid
Madrid
Paloma Plaza Roig, MD, +34 913 53 19 20, pplazaroig@unav.es
Paloma Plaza Roig, MD
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Nuria Pretel Garrido, +34 658 34 59 91, npretelgar@unav.es
Nuria Pretel Garrido
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Wound Healing, Abdominal Surgery, Scar Improvement
- Being tested
- Ozonated product-based protocol for scar hygiene and care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated product-based protocol for scar hygiene and careOther
Ozonated oil soap and ozonated oil, added to standard postoperative care
| Study group | Role | What they receive |
|---|---|---|
| Ozoaqua protocol treament + standard postoperative care | Experimental | Not described Receives: Other: Ozonated product-based protocol for scar hygiene and care |
| Standard postoperative care | No intervention | Physiological saline solution and aqueous chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (8)
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.
Measured: 3 months
Observer score on the POSAS scale at 1 month
Measured: 1 month
Patient score on the POSAS scale at 1 month
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start14 Aug 2026
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ozoaqua
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678372
- Sponsor's protocol ID
- OZOSCAR-CUN
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07678372
- Acronym / sponsor ID
- OZOSCAR-CUN
- Conditions
- Wound Healing, Abdominal Surgery, Scar Improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Laboratorios OzoaquaIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Scheduled open abdominal surgery
- Primary wound closure
- Assessable linear abdominal scar
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozonated product-based protocol for scar hygiene and careOzonated oil soap and ozonated oil, added to standard postoperative care | Other | Ozoaqua protocol treament + standard postoperative care |
Primary outcome
Observer score on the POSAS scale at 3 months, using the linear version for surgical scars
Time frame: 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 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated product-based protocol for scar hygiene and care in people with Wound Healing and Abdominal Surgery, run by Laboratorios Ozoaqua at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Gabriel Agüera Santos (+34 623 02 25 86, juan.aguera@bioithas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observer score on the POSAS scale at 3 months, using the linear version for surgical scars (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.