Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus (PILO)

• ClinicalTrials.gov Identifier: NCT06378918
• Recruitment Status: Not yet recruiting
• First Posted: April 23, 2024
• Last Update Posted: April 23, 2024
• Sponsor: University Hospital, Angers
• Information provided by (Responsible Party): University Hospital, Angers

Tracking Information

• First Submitted Date: April 16, 2024
• First Posted Date: April 23, 2024
• Last Update Posted Date: April 23, 2024
• Estimated Study Start Date: June 15, 2024
• Estimated Primary Completion Date: April 15, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2024)

healing time [ Time Frame: within 6 weeks before resection ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 19, 2024)

• Effectiveness of the 2 procedures [ Time Frame: 4 weeks ]
  Effectiveness of the puncture-aspiration and the reference technique in terms of disappearance of symptoms => Effectiveness defined by the disappearance of symptoms and characterized by the disappearance of the inflammatory triad: pain, heat and redness 4 weeks after the initial intervention. Recurrence of the abscess or acute infection before the scheduled definitive resection is considered a failure to resolve symptoms.
• Cost-utility analysis [ Time Frame: 1.5 months and 10 months ]
  Efficiency of puncture-aspiration compared to incision by a cost-utility analysis => The cost-utility analysis consists of evaluating the Differential Cost-Utility Ratio at 1.5 months (corresponding to the management of the acute phase) and at 10 months (corresponding to the overall care) from the health system perspective.
• Duration of nursing care [ Time Frame: within 6 weeks before resection ]
  Period between the date of emergency consultation and the date of the last visit of a nurse before the definitive resection => The care may be discontinuous or delayed from the urgent intervention, particularly if the abscess to be flattened secondarily after the initial intervention.
• Duration of work stoppage [ Time Frame: within 6 weeks before resection ]
  Time between initial intervention and return to work.
• Returning to work [ Time Frame: within 6 weeks before resection ]
  The time between the initial intervention and the day on which the patient feels able to resume their professional activity normally => The day on which the patient feels capable of resuming professional activity may be before the date of resumption of professional activity.
• Quality of life [ Time Frame: within 10 months ]
  Score assessed by the EQ-5D-5L questionnary during each visit with the surgeon and at each recurrence of the abscess => The EQ-5D-5L is a paper self-completed version that aim to describe and value health across a wide range of disease areas. This questionnary, developped by EuroQol group association, is a descriptive system that comprise 5 Dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and each dimension has 5 response Levels (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems)
• Healing after definitive resection [ Time Frame: 3 months after definitive resection ]
  Healing after definitive resection is defined by the absence of need for local care associated with the complete epidermization of the resection area carried out with directed healing, 3 months after the definitive resection.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus
• Official Title: PILO - Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus

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.

Detailed Description

This is a single-center, prospective, open-label, randomized study. Patients are screened and included during the emergency room consultation or a scheduled consultation. After verification of the selection criteria and provision of clear, fair and appropriate information, patients are offered to participate in the study. If they accept, consent is signed and randomization is carried out.

The procedure under study is puncture/aspiration. 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. The patient is systematically reviewed 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.

The gold standard procedure is incision of the abscess. 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 wicking is then carried out with nursing care at home until healing. A work stoppage is recommended for a period of approximately 10 days. The patient is systematically reviewed at 15 days 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.

The definitive resection procedure is carried out after the flattening of the abscess has healed. It is recommended to perform resection without closure with nursing-care healing at home with daily packings for 15 days. After the 15-day visit, changing the dressings by wicking is recommended daily until healing.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pilonidal Cyst

Intervention

• Procedure: puncture
  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.
  Other Name: aspiration
• Procedure: incision of the abscess
  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.
  Other Name: gold standard

Study Arms

• Experimental: puncture/aspiration
  The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered.
  Intervention: Procedure: puncture
• 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.
  Intervention: Procedure: incision of the abscess

Publications *

• 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.
• 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.
• 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. Erratum In: Int J Colorectal Dis. 2008 Nov;23(11):1137. Boulesteix, Anne-Laure [added].
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 19, 2024): 134
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 15, 2027
• Estimated Primary Completion Date: April 15, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Marie BOUGARD, Dr; (0)2 41 35 35 25 ext +33; Marie.Bougard@chu-angers.fr

Contact: Aurélien VENARA, Pr; (0)2 41 35 36 18 ext +33; AuVenara@chu-angers.fr

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06378918
• Other Study ID Numbers: 2023-A02791-44
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Hospital, Angers
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Angers
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Cécile JAGLIN-GRIMONPREZ; University Hospital of Angers (study promotor)

• PRS Account: University Hospital, Angers
• Verification Date: April 2024