Pilonidal sinus Skin and Connective Tissue Diseases
Conditions
Interventions
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 Aqua
Sponsors
Brothier (France)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patients with complete excisional closure evaluated by the investigator at 6 weeks post-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. % reduction of the excision volume measured by depth x area at weeks 3 and 6 2. Time in days between the date of surgery and resumption of normal activity, self-assessed by patient 3. Nature and frequency of Algostéril or Aquacel Extra-related incidents and adverse events (AEs) related to the investigation procedure, recorded using the adverse event form throughout the study | — |
Countries
France
Contacts
Public ContactMélanie Angot
Outcome results
None listed