Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection

NCT05061264 | Completed

• 1 other identifier: PVDF mesh
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective setting.

Conditions

Abdominal Wall Defect; Abdominal Wall Hernia; Abdominal Wall Infection; Abdominal Wall Fistula; Infection

Keywords

ventral hernia; mesh infection; enteric fistula; polyvinylidene mesh; synthetic mesh; abdominal wall reconstruction; complex hernia; DynaMesh

Outcome Measures

Primary Outcomes (2)

• Surgical site occurence

  any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation

  30 days

• Surgical site infection

  as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space

  30 days

Secondary Outcomes (2)

• Hernia recurrence

  6 and 36 months

• Infection recurrence

  6 and 36 months

Other Outcomes (1)

• Microbiology of mesh infection

  30 days

Study Arms (2)

Active infection group

EXPERIMENTAL

A cohort of 38 patients carrying an active infection (mesh sinus, exposed mesh or enteric fistulas) resulting from a previous hernia repair, with or without an associated recurrent ventral hernia, and submitted to abdominal wall reconstruction with PVDF mesh.

Procedure: Abdominal wall reconstruction

Clean control group

ACTIVE COMPARATOR

A cohort of 38 patients with ventral hernias, and submitted to clean ventral hernia repair with PVDF mesh.

Procedure: Abdominal wall reconstruction

Interventions

Abdominal wall reconstruction PROCEDURE

The repair of abdominal wall defects with polyvinylidene (PVDF) mesh

Also known as: Ventral hernia repair

Active infection group; Clean control group

Eligibility Criteria

• Age: 20 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study group: patients with the presence of an active chronic mesh infection (non-healing sinus, exposed mesh, or mesh-related enteric fistulas) resulting from a previous repair, or the presence of an enteric/enteroatmospheric fistula, with or without an associated abdominal wall defect
• Control group: patients with a primary or recurrent ventral hernia without previous history of infection and eligible for clean operations

You may not qualify if:

• giant ventral hernias with a volume ratio higher than 25% and loss of domicile
• patients on immunosuppressive therapy or using corticosteroids
• patients with portal hypertension
• patients with Chron´s disease
• acute postoperative mesh infection
• chronic mesh infections following inguinal hernia repair
• emergency operations.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, 05403-000, Brazil

Location

Related Publications (7)

• Birolini C, de Miranda JS, Tanaka EY, Utiyama EM, Rasslan S, Birolini D. The use of synthetic mesh in contaminated and infected abdominal wall repairs: challenging the dogma-A long-term prospective clinical trial. Hernia. 2020 Apr;24(2):307-323. doi: 10.1007/s10029-019-02035-2. Epub 2019 Sep 6.

  PMID: 31493051 BACKGROUND

• Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpelick V. PVDF as a new polymer for the construction of surgical meshes. Biomaterials. 2002 Aug;23(16):3487-93. doi: 10.1016/s0142-9612(02)00070-4.

  PMID: 12099293 BACKGROUND

• Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. doi: 10.1017/s0195941700064080. No abstract available.

  PMID: 3633903 BACKGROUND

• Haskins IN, Horne CM, Krpata DM, Prabhu AS, Tastaldi L, Perez AJ, Rosenblatt S, Poulose BK, Rosen MJ. A call for standardization of wound events reporting following ventral hernia repair. Hernia. 2018 Oct;22(5):729-736. doi: 10.1007/s10029-018-1748-6. Epub 2018 Feb 10.

  PMID: 29429064 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Hodgkinson JD, Maeda Y, Leo CA, Warusavitarne J, Vaizey CJ. Complex abdominal wall reconstruction in the setting of active infection and contamination: a systematic review of hernia and fistula recurrence rates. Colorectal Dis. 2017 Apr;19(4):319-330. doi: 10.1111/codi.13609.

  PMID: 28102927 RESULT

• Birolini C, Faro Junior MP, Terhoch CB, de Miranda JS, Tanaka EY, Utiyama EM. Microbiology of chronic mesh infection. Hernia. 2023 Aug;27(4):1017-1023. doi: 10.1007/s10029-023-02747-6. Epub 2023 Feb 9.

  PMID: 36757611 DERIVED

MeSH Terms

Conditions

Hernia, Abdominal; Infections; Hernia, Ventral

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Claudio Birolini, MD

  Hospital das Clinicas da FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phD. Director of General Surgery of the Third Division of Clinical Surgery of the Department of Surgery, Head of the Hernias and Abdominal Wall Group

Model Details: A study group submitted to abdominal wall repair with PVDF mesh in the infected setting compared to a control group submitted to abdominal wall repair with PVDF mesh in the clean setting.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: May 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From september 2021, available for 1 year
• Access Criteria: Available data to be shared with researchers interested in abdominal wall reconstruction

Locations

BR (1)