Clinical trial · Interventional
Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus
PILO - Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): change of care at the center and low recruitment rate
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Cyst | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| incision of the abscess | Procedure | — | UNRESOLVED |
| puncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- puncture/aspiration
- description
- The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered.
- interventionNames
- Procedure: puncture
- type
- ACTIVE_COMPARATOR
- label
- abscess incision
- description
- 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.
- interventionNames
- Procedure: incision of the abscess
Primary outcomes (1)
- measure
- healing time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Skin necrosis * Immunosuppression (drug-related or pathological) or diabetes * Spontaneous fistulization * Patients who do not speak French * Pregnant and/or breastfeeding women * Patients without social security coverage * Person deprived of liberty by judicial or administrative decision * Person subject to psychiatric care under duress * Person subject to a legal protection measure * Person unable to express consent
References
Publications (7)
- BACKGROUNDde Parades V, Bouchard D, Janier M, Berger A. Pilonidal sinus disease. J Visc Surg. 2013 Sep;150(4):237-47. doi: 10.1016/j.jviscsurg.2013.05.006. Epub 2013 Aug 1. PMID 23911903
- BACKGROUNDSegre D, Pozzo M, Perinotti R, Roche B; Italian Society of Colorectal Surgery. The treatment of pilonidal disease: guidelines of the Italian Society of Colorectal Surgery (SICCR). Tech Coloproctol. 2015 Oct;19(10):607-13. doi: 10.1007/s10151-015-1369-3. Epub 2015 Sep 16. PMID 26377583
- BACKGROUNDDoll D, Friederichs J, Boulesteix AL, Dusel W, Fend F, Petersen S. Surgery for asymptomatic pilonidal sinus disease. Int J Colorectal Dis. 2008 Sep;23(9):839-44. doi: 10.1007/s00384-008-0476-2. Epub 2008 May 20. PMID 18491116
- BACKGROUNDDoll D, Friederichs J, Dettmann H, Boulesteix AL, Duesel W, Petersen S. Time and rate of sinus formation in pilonidal sinus disease. Int J Colorectal Dis. 2008 Apr;23(4):359-64. doi: 10.1007/s00384-007-0389-5. PMID 18043929
- BACKGROUNDFahrni GT, Vuille-Dit-Bille RN, Leu S, Meuli M, Staerkle RF, Fink L, Dincler S, Muff BS. Five-year Follow-up and Recurrence Rates Following Surgery for Acute and Chronic Pilonidal Disease: A Survey of 421 Cases. Wounds. 2016 Jan;28(1):20-6. PMID 26824973
- BACKGROUNDHussain ZI, Aghahoseini A, Alexander D. Converting emergency pilonidal abscess into an elective procedure. Dis Colon Rectum. 2012 Jun;55(6):640-5. doi: 10.1097/DCR.0b013e31824b9527. PMID 22595842
- BACKGROUNDLasithiotakis K, Aghahoseini A, Volanaki D, Peter M, Alexander D. Aspiration for acute pilonidal abscess-a cohort study. J Surg Res. 2018 Mar;223:123-127. doi: 10.1016/j.jss.2017.09.051. Epub 2017 Nov 17. PMID 29433863