Surgical Site InfectionNCT04174976
Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair
An observational study of Surgical Site Infection, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- wall hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2017to 1 Jan 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted for wall hernia repair with mesh between 28/12/2017 and 01/01/2021 (expected number of approximately 300 patients) for which follow-up data will be available during the first post-operative year
Who may be able to join
- All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020
Who cannot join
- Emergency surgery
- Laparoscopic
- Pregnancy
- Adults under legal guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Estelle Vigneron
Nancy, 54000
Estelle Vigneron, 0619676726, e.vigneron@hotmail.fr
About this study
Official title: Morbidity of Abdominal Wall Hernia Reconstruction With Mesh: Study of Environmental Risk Factors in the Operating Room in the CHRU of Nancy- a Prospective Study
Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity.
Within our digestive surgery department (CHRU de Nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between January 2016 and December 2018. This rate is higher than those usually described in the literature.
Read more
Several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. The influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied.
If the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk.
The main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction
Read the detailed description
It's a prospective, mono-centric study carried out on a cohort of patients followed in the digestive surgery department of the CHRU of Nancy
All patients who underwent a wall hernia repair between 28/12/2017 and 28/12/2020 in the digestive and general surgery department of the CHU of Nancy were included.
During the operative time, the nurses have to fill a survey with characteristics specific to the intervention and the operating environment.
Patients in this study have been followed for at least one year at the Nancy CHRU in order to be aware of the occurence of mesh infection and surgery for mesh explantation.
- Conditions
- Surgical Site Infection
- Being tested
- wall hernia repair
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wall hernia repairProcedure or surgery
Wall hernia repair with mesh
| Study group | Role | What they receive |
|---|---|---|
| Wall hernia repair | All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020.
. Receives: Procedure: wall hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with surgical site infection
patient has at least one of the following:
purulent drainage from the deep incision. a deep incision that spontaneously dehisces, or is deliberately opened or aspirated by a surgeon, physician* or physician designee AND organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)) or culture or non-culture based microbiologic testing method is not performed. A culture or non-culture based test from the deep soft tissues of the incision that has a negative finding does not meet this criterion. AND patient has at least one of the following signs or symptoms: fever (>38°C); localized pain or tenderness.
an abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.
Measured: up to 1 year
Secondary outcomes (1)
Number of participants with surgery for mesh explantation
Surgery for mesh explantation
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start28 Dec 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estelle Vigneron, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174976
- Sponsor's protocol ID
- 2019PI187
- Status last verified
- Oct 2019
- First submitted
- 21 Nov 2019
- Last updated
- 12 Dec 2019
- Results posted
- 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 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity of Abdominal Wall Hernia Reconstruction With Mesh: Study of Environmental Risk Factors in the Operating Room in the CHRU of Nancy- a Prospective Study
- ClinicalTrials.gov ID
- NCT04174976
- Acronym / sponsor ID
- 2019PI187
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 22 Nov 2019 (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.
Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity.
Within our digestive surgery department (CHRU de Nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between January 2016 and December 2018. This rate is higher than those usually described in the literature.
Several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. The influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied.
If the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk.
The main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction
Detailed description
It's a prospective, mono-centric study carried out on a cohort of patients followed in the digestive surgery department of the CHRU of Nancy
All patients who underwent a wall hernia repair between 28/12/2017 and 28/12/2020 in the digestive and general surgery department of the CHU of Nancy were included.
During the operative time, the nurses have to fill a survey with characteristics specific to the intervention and the operating environment.
Patients in this study have been followed for at least one year at the Nancy CHRU in order to be aware of the occurence of mesh infection and surgery for mesh explantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wall hernia repair | – | Procedure: wall hernia repairAll patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for wall hernia repair with mesh between 28/12/2017 and 01/01/2021 (expected number of approximately 300 patients) for which follow-up data will be available during the first post-operative year
Key inclusion criteria (1 listed)
- All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020
Key exclusion criteria (4 listed)
- Emergency surgery
- Laparoscopic
- Pregnancy
- Adults under legal guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wall hernia repairWall hernia repair with mesh | Procedure or surgery | Wall hernia repair |
Primary outcome
Number of participants with surgical site infection
Time frame: up to 1 year
patient has at least one of the following: purulent drainage from the deep incision. a deep incision that spontaneously dehisces, or is deliberately opened or aspirated by a surgeon, physician* or physician designee AND organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)) or culture or non-culture based microbiologic testing method is not performed. A culture or non-culture based test from the deep soft tissues of the incision that has a negative finding does not meet this criterion. AND patient has at least one of the following signs or symptoms: fever (>38°C); localized pain or tenderness. an abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.
1 secondary outcome
Number of participants with surgery for mesh explantation
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- 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.
Estelle Vigneron principal investigator
Central Hospital, Nancy, France
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 Surgical Site Infection, run by Central Hospital, Nancy, France 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 1 inclusion and 4 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 12 Dec 2019. 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?
Contact Estelle Vigneron (0619676726, e.vigneron@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with surgical site infection (time frame: up to 1 year). 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 Dec 2019.