Reducing Mesh Infections in Open Hernia Repairs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01860469
Recruitment Status : Unknown
Verified May 2013 by Ali Cadili, University of Saskatchewan.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Information provided by (Responsible Party):
Ali Cadili, University of Saskatchewan

Brief Summary:
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection

Condition or disease Intervention/treatment Phase
Patients Undergoing Open Hernia Repair Patients Undergoing Ventral or Inguinal Hernia Repair Procedure: vancomycin-soaked mesh Procedure: plain mesh Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?
Study Start Date : June 2013
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: plain mesh
standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair
Procedure: plain mesh
Other Name: non vancomycin-soaked mesh
Experimental: vancomycin-soaked mesh
use of vancomycin-soaked mesh for open hernia repair
Procedure: vancomycin-soaked mesh

Primary Outcome Measures :
  1. mesh infections [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. hernia recurrence [ Time Frame: 6 months ]
  2. postoperative seroma formation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • open ventral or inguinal hernia repair

Exclusion Criteria:

  • laparoscopic hernia repair
  • non ventral or inguinal hernia repairs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01860469

Canada, Saskatchewan
Five Hills Health Region Not yet recruiting
Moose Jaw, Saskatchewan, Canada, S6H 1H3
Contact: Ali Cadili, MD, FRCSC    3066940200   
Principal Investigator: Ali Cadili, MD, FRCSc         
Sub-Investigator: Nishaan Cheddie, MD, FRCSc         
Sub-Investigator: George B Miller, MD, FRCSc         
Sponsors and Collaborators
University of Saskatchewan

Responsible Party: Ali Cadili, Clinical Assistant Professor, University of Saskatchewan Identifier: NCT01860469     History of Changes
Other Study ID Numbers: MeshVanco
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents
Anti-Infective Agents