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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients with a pilonidal sinus abscess

• Surgical indication for flattening the abscess

• Recurrent or de novo abscess

• Signature of consent to participate in the study

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
Contact Information
Primary
Aurélien VENARA, PHD
AuVenara@chu-angers.fr
(0)2 41 35 35 25
Backup
Aurélien VENARA, Pr
AuVenara@chu-angers.fr
(0)2 41 35 36 18
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2028-01-20
Participants
Target number of participants: 134
Treatments
Experimental: puncture/aspiration
The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered.
Active_comparator: abscess incision
The incision is made in the operating room under general or local anesthesia. The intervention is carried out on an outpatient basis but if necessary, short-term hospitalization is carried out. Daily drying is then carried out with nursing care at home until healing.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov