Healing effectiveness of Algosteril vs Aquacel Extra in pilonidal sinuses
- Conditions
- Pilonidal sinusSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN24794558
- Lead Sponsor
- Brothier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 238
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method