Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
研究概览
简要总结
The aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Patients with leg ulcers (venous, ischemic, traumatic or diabetic foot ulcer).
- •Patients with dehisced surgical wounds healing by second intention.
- •Patients with pressure ulcers.
- •Wound area between 1 and 250 cm2.
排除标准
- •Systemic inflammatory disease or oncological disease.
- •Wounds with clinical signs of infection.
- •Terminal situation (life expectancy less than 6 months).
- •Ulcers from other etiologies: tumours, infectious.
- •Wounds treated with negative pressure therapy.
- •Pregnancy.
- •History of sensitivity or allergy to any of the components of the study dressing.
- •In addition, criteria for withdrawal from the study will be considered:
- •Worsening of the wound according to the clinical judgment of the professional (appearance of clinical signs of infection or others).
- •Appearance of allergies or hypersensitivity to the dressing.
- •Hospital admission that interrupts or complicates the continuity of care in the Nursing Consultation.
- •Transfer to another Health District where there can be no continuity of care with the active dressing.
研究组 & 干预措施
Antioxidant dressing (active product)
干预措施: Antioxidant dressing (active product) (Device)
Usual care dressing (standard clinical practice)
干预措施: Usual care dressing that create a moist environment (standard clinical practice) (Device)
结局指标
主要结局
Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
时间窗: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
The RESVECH 2.0 is a scale for monitoring the cicatrization of the wound. It has 6 items: size of the lesion, depth/tissue concerned, edges, type of tissue in the wound bed, exudate, infection/inflammation. The scale is scored numerically and can score ranging from 0 to 35 points, wound healed and the worst possible lesion respectively
Wound size reduction
时间窗: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Difference in wound area between first and last dressing
次要结局
- Time to removal of non-viable tissue from wound bed(At baseline, after 2 week, after 4 week, after 6 week and after 8 week)
- Time required to achieve 50% reduction in wound size(Change from baseline to 8 weeks of follow up)
- Number of completely healed wounds(At baseline, after 2 week, after 4 week, after 6 week and after 8 week)
- Pain level(At baseline, after 2 week, after 4 week, after 6 week and after 8 week)
- Area of wound with bacterial load(At baseline, after 2 week, after 4 week, after 6 week and after 8 week)
研究者
Inés María Comino-Sanz
Principal Investigator
University of Jaén