Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair

NCT04174976 | Unknown

• 1 other identifier: 2019PI187
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with surgery for mesh explantation

  up to 1 year

Study Arms (1)

Wall hernia repair

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

Procedure: wall hernia repair

Interventions

wall hernia repair PROCEDURE

Wall hernia repair with mesh

Wall hernia repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Emergency surgery
• Laparoscopic
• Pregnancy
• Adults under legal guardianship

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Estelle Vigneron

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Estelle Vigneron

  CHU NANCY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estelle Vigneron

CONTACT

0619676726; e.vigneron@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: December 28, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)