Healing effectiveness of Algosteril vs Aquacel Extra in pilonidal sinuses
| ISRCTN | ISRCTN24794558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24794558 |
| EudraCT/CTIS number | 2022-A02722-41 |
| Secondary identifying numbers | RCT/PILO-ALGm/ALGc-12.2022 |
- Submission date
- 27/07/2023
- Registration date
- 28/07/2023
- Last edited
- 04/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Pilonidal disease is caused by the penetration of hairs into dimples in the gluteal (buttock) cleft and may present as an acute abscess or chronic suppuration (pus). In the chronic phase, surgery is recommended. The technique of wide excision without closure is favoured by French surgeons: under anaesthesia, the infected tissue is removed, then the wound is left open for directed healing (budding tissue develops and fills the lesion from depth to surface). Wide excision of the pilonidal sinus has a 95% recurrence-free cure rate. However, it is a high-impact procedure for patients, requiring daily, sometimes painful nursing care over a prolonged period (typically 2-3 months). The aim of this study is to demonstrate that the speed of budding tissue development is faster with Algosteril compared with Aquacel Extra.
Who can participate?
Patients with a pilonidal sinus that needs to be excised
What does the study involve?
Patients will be randomly assigned to either the Algostéril group or the Aquacel Extra group. After surgery, the excision filling will be evaluated at weeks 3 and 6.
What are the possible benefits and risks of participating?
Participants treated with Algostéril may benefit from a reduction of the duration of healing. No risks have been identified. Algosteril and Aquacel Extra will be used as indicated.
Where is the study run from?
The study will be run from several French hospitals
When is the study starting and how long is it expected to run for?
December 2022 to July 2026
Who is funding the study?
Laboratoires Brothier (France)
Who is the main contact?
Mélanie Angot, melanie.angot@brothier.com
Contact information
Public
Brothier
41 rue de Neuilly
Nanterre
92735
France
| Phone | +33 (0)1 56 38 30 00 |
|---|---|
| recherche.clinique@brothier.com |
Study information
| Study design | Multicenter prospective comparative randomized parallel-group open-label superiority study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Care home, Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in the web format, please use contact details to request a participant information sheet |
| Scientific title | Multicenter, prospective, randomized clinical trial evaluating the healing efficacy of Algosteril® vs Aquacel Extra® in complete pilonidal sinus excisions |
| Study acronym | ALPI |
| Study objectives | Algostéril is better than Aquacel Extra for the healing of the pilonidal sinus excision |
| Ethics approval(s) |
Approved 21/04/2023, CPP Nord-Ouest IV (Bâtiment ex USNB- 6 rue du Pr Laguesse - CHRU Lille - CS70001, Lille, 59037, France; -; cppnordouestiv@univ-lille.fr), ref: 22.04704.000166 |
| Health condition(s) or problem(s) studied | Pilonidal sinus |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Algostéril, Aquacel Extra |
| Primary outcome measure | % of patients with complete excisional closure evaluated by the investigator at 6 weeks post-operative |
| Secondary outcome measures | 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 |
| Overall study start date | 15/12/2022 |
| Completion date | 01/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 238 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2023 |
| Date of final enrolment | 01/04/2026 |
Locations
Countries of recruitment
- France
Study participating centres
Paris
75014
France
Paris
75015
France
Paris
75020
France
saint Mandé
94160
France
La Tronche
38700
France
Brest
29240
France
Talence
33401
France
Saint Herblain
44800
France
Poissy
78303
France
Sponsor information
Industry
41 rue de Neuilly
Nanterre
92735
France
| Phone | +33 (0)1 56 38 30 00 |
|---|---|
| Recherche.clinique@brothier.com | |
| Website | http://www.brothier.com |
"ROR" |
https://ror.org/007jkh405 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
04/04/2025: The recruitment end date was changed from 01/02/2025 to 01/04/2026. The overall study end date was changed from 31/03/2025 to 01/07/2026.
28/07/2023: Study's existence confirmed by the CPP Nord-Ouest IV.
