Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment
研究概览
简要总结
The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).
Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units.
- •Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
- •Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center.
- •Ability to cooperate in necessary evaluations.
- •Informed consent for inclusion in the study, either from the participant themselves or from their legal representative.
排除标准
- •Participants diagnosed with any of the following conditions:
- •Ulcers with exposed bone tissue.
- •Neoplastic-origin ulcers.
- •Ulcers lasting more than 18 months.
- •Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.
研究组 & 干预措施
Acetic Acid
Topic application of a Acetic Acid 2% solution for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments
干预措施: Acetic Acid (Drug)
Control group
Topic application of Prontosan® for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments
干预措施: Prontosan (Drug)
结局指标
主要结局
Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment
时间窗: 8 weeks
The assessment of the ulcer will include measuring its area through digital planimetry.
次要结局
- Percentage of participants with ulcer healing at 12 weeks from the start of treatment.(12 weeks)
- Number of adverse reactions associated with the treatment, collected from the medical record.(12 weeks)
- Percentage of participants with ulcer healing at 4 weeks from the start of treatment.(4 weeks)
- Time (days) to ulcer healing from the start of treatment.(up to 12 weeks)
- Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale.(8 weeks)
- The healthcare expenditure associated with each branch of the study(12 weeks)
- Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment(4 weeks)
- Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment(12 weeks)