Prospective, Randomized, Evaluator-blinded Clinical Study to Compare a Post-surgical Scar Care Protocol Using OzoAqua Products Versus Standard Care in Open Abdominal Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Observer score on the POSAS scale at 3 months, using the linear version for surgical scars
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Scheduled open abdominal surgery
- •Primary wound closure
- •Assessable linear abdominal scar
- •Signed informed consent
- •Ability to complete 3-month follow-up
排除标准
- •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
研究组 & 干预措施
Ozoaqua protocol treament + standard postoperative care
干预措施: Ozonated product-based protocol for scar hygiene and care (Other)
Standard postoperative care
Physiological saline solution and aqueous chlorhexidine
结局指标
主要结局
Observer score on the POSAS scale at 3 months, using the linear version for surgical scars
时间窗: 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.
次要结局
- Patient score on the POSAS scale at 3 months(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(1 month)
- Scar pain measured using a visual analogue scale (VAS) at the 2-week, 1-month and 3-month visits(3 months)
- Scar pruritus measured using a numerical rating scale at the 2-week, 1-month and 3-month visits.(3 months)
- Patient global satisfaction with the scar, measured using a numerical rating scale at 3 months(3 months)
- Need for rescue scar treatment during the follow-up period(3 months)