Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Percent of Fibrin changes from day 0 to day 15
研究概览
简要总结
The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient between 18 and 90 years old
- •patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers
- •pressure ulcers were less than 2cm-deep
- •limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8
- •signed informed consent
排除标准
- •patients pregnant or lactating
- •patients with neuropathy
- •patients perforant ulcer of the foot
- •patients with dementia
结局指标
主要结局
Percent of Fibrin changes from day 0 to day 15
次要结局
- Percent of healing changes from day 0 to day 15
