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Reducing Mesh Infections in Open Hernia Repairs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Ali Cadili, University of Saskatchewan.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01860469
First Posted: May 22, 2013
Last Update Posted: May 22, 2013
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.
Information provided by (Responsible Party):
Ali Cadili, University of Saskatchewan
  Purpose
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection

Condition Intervention 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
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Ali Cadili, University of Saskatchewan:

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

Secondary Outcome Measures:
  • hernia recurrence [ Time Frame: 6 months ]
  • postoperative seroma formation [ Time Frame: 6 months ]

Study Start Date: June 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

Inclusion Criteria:

  • open ventral or inguinal hernia repair

Exclusion Criteria:

  • laparoscopic hernia repair
  • non ventral or inguinal hernia repairs
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01860469


Locations
Canada, Saskatchewan
Five Hills Health Region Not yet recruiting
Moose Jaw, Saskatchewan, Canada, S6H 1H3
Contact: Ali Cadili, MD, FRCSC    3066940200    alicadili1@gmail.com   
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
  More Information

Responsible Party: Ali Cadili, Clinical Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01860469     History of Changes
Other Study ID Numbers: MeshVanco
First Submitted: May 18, 2013
First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: May 2013

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