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

NCT06378918 | Recruiting

• 1 other identifier: 2023-A02791-44
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pilonidal Cyst

Keywords

Pilonidal Cyst; abcess; puncture; incision; intergluteal groove

Outcome Measures

Primary Outcomes (1)

• healing time

  Compare the duration of wound healing between the puncture-aspiration and Incision groups =\> The healing time is defined by the time between the abscess flattens and the moment the skin is epidermised. In this case, it involves stopping the use of nursing care and stopping dressings. Healing is checked by the investigator using a photo taken by the patient. The date of healing is then recorded by the patient in the logbook. In the event of a recurrence of the abscess, with the need for an incision following the acute episode, the healing time is added to the duration of the previous episode.

  within 6 weeks before resection

Secondary Outcomes (7)

• Effectiveness of the 2 procedures

  4 weeks

• Cost-utility analysis

  1.5 months and 10 months

• Duration of nursing care

  within 6 weeks before resection

• Duration of work stoppage

  within 6 weeks before resection

• Returning to work

  within 6 weeks before resection

Study Arms (2)

puncture/aspiration

EXPERIMENTAL

The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered.

Procedure: puncture

abscess incision

ACTIVE COMPARATOR

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.

Procedure: incision of the abscess

Interventions

puncture PROCEDURE

Local anesthesia is previously carried out with 2-5 cc of 1% lidocaine. The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered. A work stoppage is recommended until the day after the puncture/aspiration but the duration is left to the discretion of the surgeon. A visit is systematically realised 15 days after the puncture/aspiration with a recommendation for earlier consultation in the event of persistence of redness, discharge, pain or onset of fever. If these symptoms recur or persist, it is recommended to make an incision with packing. In the event of fistulization following the puncture, associated with discharge and skin necrosis, local nursing care is recommended. The definitive resection procedure is then planned 4 to 6 weeks after the puncture/aspiration if the evolution is favorable.

Also known as: aspiration

puncture/aspiration

incision of the abscess PROCEDURE

This is carried out according to the habits of the department: in the operating room under general or local anesthesia or in consultation (or emergencies) under local anesthesia. The procedure 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. A work stoppage is recommended for a period of approximately 10 days. A visit is systematically realised 15 days after the incision with a recommendation for earlier consultation in the event of persistence of redness, discharge, pain or onset of fever. If these symptoms recur or persist, it is recommended to make an incision with packing. The definitive resection procedure is then planned 4 to 6 weeks after the initial operation if the evolution is favorable.

Also known as: gold standard

abscess incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Antibiotic therapy initiated before the emergency room consultation or before the scheduled consultation
• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49000, France

RECRUITING

Related Publications (7)

• de 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 BACKGROUND

• Segre 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 BACKGROUND

• Doll 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 BACKGROUND

• Doll 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 BACKGROUND

• Fahrni 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 BACKGROUND

• Hussain 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 BACKGROUND

• Lasithiotakis 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 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus; Surgical Wound

Interventions

Punctures

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Aurélien VENARA, PHD

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélien VENARA, PHD

CONTACT

(0)2 41 35 35 25; AuVenara@chu-angers.fr

Aurélien VENARA, Pr

CONTACT

(0)2 41 35 36 18; AuVenara@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 23, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)