Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair

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.

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

Study Overview

• Status: Unknown
• Conditions: Surgical Site Infection
• Intervention / Treatment: Procedure: wall hernia repair

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • Estelle Vigneron
    • Contact: Estelle Vigneron; Phone Number: 0619676726; Email: e.vigneron@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Wall hernia repair; All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020. .	Procedure: wall hernia repair; Wall hernia repair with mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with surgery for mesh explantation	Surgery for mesh explantation	up to 1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Estelle Vigneron, CHU Nancy

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2017
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (ACTUAL): November 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Wound Infection; Hernia; Infections; Hernia, Ventral; Surgical Wound Infection; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: 2019PI187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No