Trial record 10 of 179 for:    Open Studies | Hernia NOT disc

Reducing Mesh Infections in Open Hernia Repairs

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
Ali Cadili, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01860469
First received: May 18, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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 University of Saskatchewan:

Primary Outcome Measures:
  • mesh infections [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hernia recurrence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • postoperative seroma formation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ali Cadili, Clinical Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01860469     History of Changes
Other Study ID Numbers: MeshVanco
Study First Received: May 18, 2013
Last Updated: May 18, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 28, 2014