Pilonidal sinus disease.
V de Parades, D Bouchard, M Janier...
https://pubmed.ncbi.nlm.nih.gov/23911903Actively Recruiting
Led by University Hospital, Angers · Updated on 2025-03-26
134
Participants Needed
1
Research Sites
43 weeks
Total Duration
Pilonidal disease involves abscesses in the area between the buttocks and is commonly treated by making an incision to drain the abscess, followed by daily care until healing, which typically takes about 21 days. This research evaluates two approaches to managing pilonidal abscesses before definitive surgery: the traditional incision method and a newer puncture technique combined with antibiotics. The study aims to compare healing times, costs, quality of care, support duration, and work stoppage length between these methods. The trial is a single-center, open-label, randomized study comparing puncture/aspiration using a 16 gauge needle under local anesthesia with antibiotic coverage, against standard incision of the abscess performed under general or local anesthesia. After initial treatment, patients are reviewed 15 days later, with further care or surgery planned 4 to 6 weeks after the abscess has flattened. The incision group receives daily nursing care at home until healing, while the puncture group may require additional intervention if symptoms persist. Participants will undergo regular assessments including healing time before surgery, effectiveness of procedures, nursing care duration, work stoppage length, quality of life surveys, and healing after definitive surgery. Follow-ups occur up to 10 months post-treatment to monitor outcomes. The study includes visits at 15 days post-procedure and plans for definitive surgery after healing, with ongoing evaluation of symptoms and recovery progress throughout the participation period.
CONDITIONS
Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the PiLOnidal Sinus
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Complete this quick 3-step screening to check your eligibility
Duration - Up to the day of the emergency room or scheduled consultation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 weeks until definitive resection
Participants receive either a simple puncture with local anesthesia and antibiotic coverage or an abscess incision under general or local anesthesia, possibly with short hospitalization. Work stoppage is recommended for a short period after the procedure. Nursing care at home with daily dressings is provided until healing.
1 procedure visit and 1 follow-up visit at 15 days, with additional visits as needed for symptoms or complications
Duration - Approximately 15 days post-resection
Participants undergo definitive resection after abscess healing, with nursing care and daily dressings at home for about 15 days until healing.
1 follow-up visit at 15 days post-resection and daily dressing care at home
Total: 1 location
1
CHU Angers
Angers, France, 49000
Actively Recruiting
A
Aurélien VENARA, PHD
A
Aurélien VENARA, Pr
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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