Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06378918

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

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

134

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence. An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov. The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage.

CONDITIONS

Official 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 the consultation
  • Presence of skin necrosis
  • Immunosuppression or diabetes
  • Spontaneous fistulization
  • Patients who do not speak French
  • Pregnant or breastfeeding women
  • Patients without social security coverage
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under psychiatric care against their will
  • Persons under legal protection
  • Persons unable to give consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Angers

Angers, France, 49000

Actively Recruiting

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Research Team

A

Aurélien VENARA, PHD

CONTACT

A

Aurélien VENARA, Pr

CONTACT

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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