NCT05513885

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 23, 2022

Last Update Submit

June 28, 2024

Conditions

Pilonidal Cysts

Outcome Measures

Primary Outcomes (1)

  • Main germs incidence rate

    Calculation of the the incidence rates of the main germs

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

August 24, 2022

Study Start

June 24, 2024

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)