Bacterial Ecology of Pilonidal Cysts (PILOBAC)

Bacterial ecology of pilonidal cysts Single centre retrospective exploratory study of medical data contained in the medical records of patients operated on in the centre between 01/08/2020 and 30/11/2020.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Cysts

Detailed Description

From the medical records of a series of patients treated for pilonidal cysts:

1. Describe the bacteriological analyses performed on a series of non-abscessed pilonidal cysts before laser treatment
2. Compare the bacterial flora of cysts operated on in the first instance and those reoperated on

This is a retrospective monocentric study of medical data contained in the medical records of patients operated on for pilonidal cysts and who received the same protocol:

• Antibiotic prophylaxis (injection of 2g of Augmentin)
• Treatment of the cyst by laser, under general anaesthesia, after dilatation of the pilonidal sinus, evisceration and bacteriological swabbing.
• Post-operative monitoring and local care

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Recruiting
    • Clinique de la Sauvegarde
    • Contact: Beanjamin DARNIS, MD; Phone Number: 33 04-37-49-66-77; Email: benjamin.darnis@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients operated on for pilonidal cysts and who received the same protocol:

• Antibiotic prophylaxis (injection of 2g of Augmentin)
• Treatment of the cyst by laser, under general anaesthesia, after dilatation of the pilonidal sinus, evisceration and bacteriological swabbing.
• Post-operative monitoring and local care

Description

Inclusion Criteria:

• Patient aged 18 years or older,
• Patient who has been informed about the research;
• Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure.

Exclusion Criteria:

• Patient under legal protection, guardianship or curatorship;
• Patient who has indicated his opposition to the use of his data;
• Patient undergoing emergency surgery for an abscess.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main germs incidence rate	Calculation of the the incidence rates of the main germs	Day 1

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Cysts; Pilonidal Sinus
• Other Study ID Numbers: COS-RGDS-2020-12-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No