The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial

NCT03702153 | Completed

• 1 other identifier: PPM - Prospective
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Abdominal wall reconstruction in patients presenting with enteric fistulas and mesh infection is challenging. There is a consensus that synthetic mesh must be avoided in infected operations. The alternatives to using synthetic mesh, such as component separation techniques and biologic mesh, present disappointing results with expressive wound infection and hernia recurrence rates. Methods: A prospective clinical trial designed to evaluate the short and the long-term outcomes of patients submitted to elective abdominal wall repair with synthetic mesh in the dirty-infected setting, and compared to a cohort of patients submitted to clean ventral hernia repairs.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Surgical site occurrence

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

  30 days

Secondary Outcomes (4)

• Surgical Site infection

  30 days

• Surgical site occurrence requiring procedural intervention

  30 days

• Ventral hernia recurrence

  36 months

• Mesh infection recurrence

  36 months

Other Outcomes (1)

• Microbiology of mesh infection

  30 days

Study Arms (2)

Infected abdominal wall group

EXPERIMENTAL

A cohort of 40 patients carrying an active chronic mesh infection (mesh sinus, exposed mesh or mesh related enteric fistulas) resulting from a previous hernia repair, with or without an associated recurrent ventral hernia, and submitted to abdominal wall reconstruction with synthetic mesh.

Procedure: Abdominal wall reconstruction

Clean control group

ACTIVE COMPARATOR

A cohort of 40 patients with ventral hernias, and submitted to clean ventral hernia repair with synthetic mesh.

Procedure: Abdominal wall reconstruction

Interventions

Abdominal wall reconstruction PROCEDURE

The repair of abdominal wall defects with polypropylene mesh

Also known as: Ventral hernia repair

Clean control group; Infected abdominal wall group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 hepatic cirrhosis and portal hypertension
• 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 (13)

• Choi JJ, Palaniappa NC, Dallas KB, Rudich TB, Colon MJ, Divino CM. Use of mesh during ventral hernia repair in clean-contaminated and contaminated cases: outcomes of 33,832 cases. Ann Surg. 2012 Jan;255(1):176-80. doi: 10.1097/SLA.0b013e31822518e6.

  PMID: 21677561 BACKGROUND

• Szczerba SR, Dumanian GA. Definitive surgical treatment of infected or exposed ventral hernia mesh. Ann Surg. 2003 Mar;237(3):437-41. doi: 10.1097/01.SLA.0000055278.80458.D0.

  PMID: 12616130 BACKGROUND

• Johnson EK, Tushoski PL. Abdominal wall reconstruction in patients with digestive tract fistulas. Clin Colon Rectal Surg. 2010 Sep;23(3):195-208. doi: 10.1055/s-0030-1262988.

  PMID: 21886470 BACKGROUND

• Franklin ME Jr, Trevino JM, Portillo G, Vela I, Glass JL, Gonzalez JJ. The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc. 2008 Sep;22(9):1941-6. doi: 10.1007/s00464-008-0005-y. Epub 2008 Jul 2.

  PMID: 18594919 BACKGROUND

• Miserez M, Fitzgibbons RJ Jr, Schumpelick V. Hernia surgery and contamination: biological mesh and nothing else? Hernia. 2013 Feb;17(1):1. doi: 10.1007/s10029-013-1044-4. Epub 2013 Jan 17. No abstract available.

  PMID: 23324870 BACKGROUND

• Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.

  PMID: 22763262 BACKGROUND

• Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14.

  PMID: 22415440 BACKGROUND

• Rosen MJ, Krpata DM, Ermlich B, Blatnik JA. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013 Jun;257(6):991-6. doi: 10.1097/SLA.0b013e3182849871.

  PMID: 23426340 BACKGROUND

• Birolini C, Utiyama EM, Rodrigues AJ Jr, Birolini D. Elective colonic operation and prosthetic repair of incisional hernia: does contamination contraindicate abdominal wall prosthesis use? J Am Coll Surg. 2000 Oct;191(4):366-72. doi: 10.1016/s1072-7515(00)00703-1.

  PMID: 11030241 BACKGROUND

• Antonopoulos IM, Nahas WC, Mazzucchi E, Piovesan AC, Birolini C, Lucon AM. Is polypropylene mesh safe and effective for repairing infected incisional hernia in renal transplant recipients? Urology. 2005 Oct;66(4):874-7. doi: 10.1016/j.urology.2005.04.072.

  PMID: 16230159 BACKGROUND

• Birolini C, de Miranda JS, Utiyama EM, Rasslan S. A retrospective review and observations over a 16-year clinical experience on the surgical treatment of chronic mesh infection. What about replacing a synthetic mesh on the infected surgical field? Hernia. 2015 Apr;19(2):239-46. doi: 10.1007/s10029-014-1225-9. Epub 2014 Feb 9.

  PMID: 24509890 BACKGROUND

• 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

• 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 DERIVED

MeSH Terms

Conditions

Infections; Hernia, Ventral

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

Hernia, Abdominal; 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 Clínicas 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

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

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: January 1, 2012
• Primary Completion: February 28, 2015
• Study Completion: February 28, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From march 2018, available for 1 year
• Access Criteria: Available data to be shared with researchers interested in abdominal wall reconstruction

Locations

BR (1)