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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Juan Gabriel Agüera Santos
- Telefoonnummer: +34 623 02 25 86
- E-mail: juan.aguera@bioithas.com
Studie Locaties
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Navarre
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Pamplona, Navarre, Spanje, 31008
- Clínica Universidad de Navarra
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Contact:
- Nuria Pretel Garrido
- Telefoonnummer: +34 658 34 59 91
- E-mail: npretelgar@unav.es
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Ozoaqua protocol treament + standard postoperative care
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Ozonated oil soap and ozonated oil, added to standard postoperative care
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Geen tussenkomst: Standard postoperative care
Physiological saline solution and aqueous chlorhexidine
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Observer score on the POSAS scale at 3 months, using the linear version for surgical scars
Tijdsspanne: 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:
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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient score on the POSAS scale at 3 months
Tijdsspanne: 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
|
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Observer score on the POSAS scale at 1 month
Tijdsspanne: 1 month
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1 month
|
|
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Patient score on the POSAS scale at 1 month
Tijdsspanne: 1 month
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1 month
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Surgical wound complications within the first month after the intervention
Tijdsspanne: 1 month
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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.
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1 month
|
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Scar pain measured using a visual analogue scale (VAS) at the 2-week, 1-month and 3-month visits
Tijdsspanne: 3 months
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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.
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3 months
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Scar pruritus measured using a numerical rating scale at the 2-week, 1-month and 3-month visits.
Tijdsspanne: 3 months
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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
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Patient global satisfaction with the scar, measured using a numerical rating scale at 3 months
Tijdsspanne: 3 months
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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
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3 months
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Need for rescue scar treatment during the follow-up period
Tijdsspanne: 3 months
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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
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3 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Treatment-related cutaneous adverse events during the follow-up period
Tijdsspanne: 3 months
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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.
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3 months
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Treatment adherence
Tijdsspanne: 3 months
|
Treatment adherence will be assessed at each visit through a directed interview with the patient, in which they will be asked whether the topical product has been applied according to the regimen specified in the protocol.
Any missed applications, temporary interruptions, incorrect application, or relevant deviations in product use will be recorded.
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3 months
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Adverse events during the follow-up period
Tijdsspanne: 3 months
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Any adverse event will be recorded, defined as any unfavourable medical occurrence or clinically relevant change in the patient's health status, regardless of its possible relationship with the study product/intervention.
In addition, any relevant modification to concomitant medical treatments during the follow-up period will be documented.
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3 months
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Medewerkers en onderzoekers
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Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- OZOSCAR-CUN
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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