ISRCTN24794558
Active, not recruiting
未知
Multicenter, prospective, randomized clinical trial evaluating the healing efficacy of Algosteril® vs Aquacel Extra® in complete pilonidal sinus excisions
Brothier (France)0 sites238 target enrollmentJuly 28, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Brothier (France)
- Enrollment
- 238
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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