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

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.

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.

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.

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.

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.

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

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

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.

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.

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.