Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06378918

Comparison of Simple Puncture Versus Incision for Abscess Treatment in Pilonidal Sinus Disease

Led by University Hospital, Angers · Updated on 2025-03-26

134

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the PiLOnidal Sinus

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with a pilonidal sinus abscess
  • Surgical indication for flattening the abscess
  • Recurrent or new abscess
  • Signed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Antibiotic therapy started before consultation
  • Presence of skin necrosis
  • Immunosuppression or diabetes
  • Spontaneous fistulization
  • Non-French speakers
  • Pregnant or breastfeeding women
  • Lack of social security coverage
  • Legal or judicial restrictions or protections
  • Inability to give consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

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)

Treatment

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

Treatment

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

Trial Site Locations

Total: 1 location

1

CHU Angers

Angers, France, 49000

Actively Recruiting

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Research Team

A

Aurélien VENARA, PHD

A

Aurélien VENARA, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Five-year Follow-up and Recurrence Rates Following Surgery for Acute and Chronic Pilonidal Disease: A Survey of 421 Cases.

Gabriela Tonia Fahrni, Raphael Nicolas Vuille-Dit-Bille, Svenja Leu...

https://pubmed.ncbi.nlm.nih.gov/26824973