Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-16
Brief Title:
Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
PILO - Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PILO
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 Clinicaltrialsgov
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
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 Clinicaltrialsgov
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 punctureaspiration 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 punctureaspiration but the duration is left to the discretion of the surgeon The patient is systematically reviewed 15 days after the punctureaspiration 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 punctureaspiration 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
The procedure under study is punctureaspiration 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 punctureaspiration but the duration is left to the discretion of the surgeon The patient is systematically reviewed 15 days after the punctureaspiration 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 punctureaspiration 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None