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

Pilonidal Cyst Clinical Trial

— PILO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378918
• Other study ID #: 2023-A02791-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: April 15, 2027

Study information

• Verified date: April 2024
• Source: University Hospital, Angers
• Contact: Marie BOUGARD, Dr
• Phone: (0)2 41 35 35 25
• Email: Marie.Bougard[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Pilonidal Cyst
• Pilonidal Sinus

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

References & 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. — View Citation

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]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effectiveness of the 2 procedures	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.	4 weeks
Secondary	Cost-utility analysis	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.	1.5 months and 10 months
Secondary	Duration of nursing care	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.	within 6 weeks before resection
Secondary	Duration of work stoppage	Time between initial intervention and return to work.	within 6 weeks before resection
Secondary	Returning to work	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.	within 6 weeks before resection
Secondary	Quality of life	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)	within 10 months
Secondary	Healing 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.	3 months after definitive resection