ISRCTN24794558进行中（未招募）Unknown
Multicenter, prospective, randomized clinical trial evaluating the healing efficacy of Algosteril® vs Aquacel Extra® in complete pilonidal sinus excisions
Brothier (France)0 个研究点目标入组 238 人开始时间: 2023年7月28日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 238
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult with sacrococcygeal pilonidal sinus:
- •1.1. Non-recurrent
- •1.2. Who must undergo excision down to the fascia with an electric scalpel
- •1.3. With an excision length of between 5 and 12 cm
- •1.4. Which will be left to undergo directed healing
- •2. Which may be seen again as an outpatient at weeks 3 and 6
- •3. Affiliated with a social security scheme
- •4. Who have read and understood the information note and signed a written informed consent to participate in the clinical investigation
排除标准
- •1. Pilonidal sinus requiring simple flattening and/or with associated anal fistula
- •2. Verneuil disease and/or uncontrolled diabetes (> 2g/l)
- •3. Treated with long-term anti-inflammatory drugs, chemotherapy or immunocompromised
- •4. Undergoing or having undergone pelvic radiotherapy
- •5. Known to be allergic to constituents of study products
- •6. Concurrently participating in another study that may have an impact on wound healing
- •7. Pregnant or nursing woman
- •8. Person deprived of liberty by judicial or administrative decision or person subject to a legal protective measure
研究者
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