Abdominal InfectionMOCOMINCT06682091
Management and Outcome of Mesh Infection After Abdominoplasty in a Tertiary Care Centre
An observational study of Abdominal Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Hernia repair is among most frequent surgical interventions. The use of abdominal mesh in hernia repair has become the Gold Standard strategy, reducing the risk of relapse. The mesh infection risk is estimated lower than 1% in simple situations, but can increase up to 20% in complicated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Infection
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 1 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects taken in care for abdominal mesh infection in the Hospices Civils de Lyon from 2010 to 2023.
Who may be able to join
- parietal mesh infection
- age > 18
Who cannot join
- Non French speaking patients.
- Persons under tutorship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon
Lyon, 69004
About this study
Official title: Management and Outcome of Mesh Infections After Abdominoplasty in a Tertiary Care Center in France
Hernia repair is among most frequent surgical interventions. The use of abdominal mesh in hernia repair has become the Gold Standard strategy, reducing the risk of relapse.
The mesh infection risk is estimated lower than 1% in simple situations, but can increase up to 20% in complicated patients. Risk factors are well known, but we lack data regarding the therapeutic strategies and outcomes.
This study aims to describe the characteristics and management of abdominal mesh infections, and the related outcomes.
- Conditions
- Abdominal Infection
- Keywords
- mesh infection, abdominoplasty
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients admitted for an abdominal mesh infection at Hospices Civils de Lyon | No intervention. Retrospective data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure.
Clinical failure = persistance of the infection. Time of failure is the time of change of therapeutic strategy.
Measured: Retrospective analysis from initial treatment to any treatment failure within 2010 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2013
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682091
- Sponsor's protocol ID
- 69HCL24_0567
- Acronym
- MOCOMI
- Status last verified
- Nov 2024
- First submitted
- 7 Jun 2024
- Last updated
- 12 Nov 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcome of Mesh Infections After Abdominoplasty in a Tertiary Care Center in France
- ClinicalTrials.gov ID
- NCT06682091
- Acronym / sponsor ID
- MOCOMI / 69HCL24_0567
- Conditions
- Abdominal Infection
- Keywords
- mesh infection, abdominoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 12 Nov 2024 (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.
Hernia repair is among most frequent surgical interventions. The use of abdominal mesh in hernia repair has become the Gold Standard strategy, reducing the risk of relapse.
The mesh infection risk is estimated lower than 1% in simple situations, but can increase up to 20% in complicated patients. Risk factors are well known, but we lack data regarding the therapeutic strategies and outcomes.
This study aims to describe the characteristics and management of abdominal mesh infections, and the related outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients admitted for an abdominal mesh infection at Hospices Civils de Lyon | – | –No intervention. Retrospective data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects taken in care for abdominal mesh infection in the Hospices Civils de Lyon from 2010 to 2023.
Key inclusion criteria (2 listed)
- parietal mesh infection
- age > 18
Key exclusion criteria (2 listed)
- Non French speaking patients.
- Persons under tutorship or curatorship.
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
Treatment failure.
Time frame: Retrospective analysis from initial treatment to any treatment failure within 2010 to 2023
Clinical failure = persistance of the infection. Time of failure is the time of change of therapeutic strategy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Abdominal Infection, run by Hospices Civils de Lyon 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure. (time frame: Retrospective analysis from initial treatment to any treatment failure within 2010 to 2023). 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 12 Nov 2024.