Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174976
• Other study ID #: 2019PI187
• Status: Recruiting
• Start date: December 28, 2017
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2019
• Source: Central Hospital, Nancy, France
• Contact: Estelle Vigneron
• Phone: 0619676726
• Email: e.vigneron[@]hotmail.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020

Exclusion Criteria:

• Emergency surgery

• Laparoscopic

• Pregnancy

• Adults under legal guardianship

Related Conditions & MeSH terms

• Hernia, Ventral
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• wall hernia repair
Wall hernia repair with mesh

Locations

Country	Name	City	State
France	Estelle Vigneron	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 year
Secondary	Number of participants with surgery for mesh explantation	Surgery for mesh explantation	up to 1 year