- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860469
Reducing Mesh Infections in Open Hernia Repairs
May 18, 2013 updated by: Ali Cadili, University of Saskatchewan
Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Saskatchewan
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Moose Jaw, Saskatchewan, Canada, S6H 1H3
- Five Hills Health Region
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Contact:
- Ali Cadili, MD, FRCSC
- Phone Number: 3066940200
- Email: alicadili1@gmail.com
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Principal Investigator:
- Ali Cadili, MD, FRCSc
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Sub-Investigator:
- Nishaan Cheddie, MD, FRCSc
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Sub-Investigator:
- George B Miller, MD, FRCSc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- open ventral or inguinal hernia repair
Exclusion Criteria:
- laparoscopic hernia repair
- non ventral or inguinal hernia repairs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: plain mesh
standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair
|
Other Names:
|
Experimental: vancomycin-soaked mesh
use of vancomycin-soaked mesh for open hernia repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mesh infections
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hernia recurrence
Time Frame: 6 months
|
6 months
|
postoperative seroma formation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
May 18, 2013
First Submitted That Met QC Criteria
May 18, 2013
First Posted (Estimate)
May 22, 2013
Study Record Updates
Last Update Posted (Estimate)
May 22, 2013
Last Update Submitted That Met QC Criteria
May 18, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MeshVanco
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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