An interventional study of puncture and incision of the abscess in Pilonidal Cyst, sponsored by University Hospital, Angers. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 5 is below the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered.
Procedure: puncture
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
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.
Also known as: aspiration
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
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.
Time frame: 6 weeks
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.
Time frame: 4 weeks
Cost analysis
Total cost of each care pathway for the acute phase of a pilonidal sinus abscess, from a health insurance perspective.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Duration of work stoppage
Time between initial intervention and return to work.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Plan to share: No — Insufficient and partial data collected
Ran from Mar 2025 to primary completion in Dec 2025, 8 months.
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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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