Pilonidal CystsPILOBACNCT05513885
Bacterial Ecology of Pilonidal Cysts
An observational study of Pilonidal Cysts, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Cysts
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique de la Sauvegarde
Lyon, 69009
Beanjamin DARNIS, MD, 04-37-49-66-77 ext. 33, benjamin.darnis@hotmail.fr
About this study
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.
Read the detailed description
From the medical records of a series of patients treated for pilonidal cysts:
- Describe the bacteriological analyses performed on a series of non-abscessed pilonidal cysts before laser treatment
- 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
- Conditions
- Pilonidal Cysts
- Medical subject headings
- Pilonidal Sinus
What is being measured
The primary outcome is the main question the study is designed to answer.
Main germs incidence rate
Calculation of the the incidence rates of the main germs
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start24 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal CystsStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513885
- Sponsor's protocol ID
- COS-RGDS-2020-12-003
- Acronym
- PILOBAC
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Ecology of Pilonidal Cysts
- ClinicalTrials.gov ID
- NCT05513885
- Acronym / sponsor ID
- PILOBAC / COS-RGDS-2020-12-003
- Conditions
- Pilonidal Cysts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
From the medical records of a series of patients treated for pilonidal cysts:
- Describe the bacteriological analyses performed on a series of non-abscessed pilonidal cysts before laser treatment
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main germs incidence rate
Time frame: Day 1
Calculation of the the incidence rates of the main germs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Cysts, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main germs incidence rate (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.