Multicenter, prospective, randomized clinical trial evaluating the healing efficacy of Algosteril® vs Aquacel Extra® in complete pilonidal sinus excisions
Pilonidal sinus
Patients were randomized (Interactive Web Response System [IWRS]) during surgery after excision of the pilonidal sinus. According to the randomization, patients will be treated with Algostéril or Aquacel Extra. The dressing will be renewed by the nurse at the patient’s home in accordance with the note to use. The duration of follow-up will be 6 weeks.
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