Back to resultsReducing Mesh Infections in Open Hernia Repairs
Primary Purpose
Patients Undergoing Open Hernia Repair, Patients Undergoing Ventral or Inguinal Hernia Repair
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
vancomycin-soaked mesh
plain mesh
Sponsored by
About this trial
This is an interventional prevention trial for Patients Undergoing Open Hernia Repair
Eligibility Criteria
Inclusion Criteria:
- open ventral or inguinal hernia repair
Exclusion Criteria:
- laparoscopic hernia repair
- non ventral or inguinal hernia repairs
Sites / Locations
- Five Hills Health Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
plain mesh
vancomycin-soaked mesh
Arm Description
standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair
use of vancomycin-soaked mesh for open hernia repair
Outcomes
Primary Outcome Measures
mesh infections
Secondary Outcome Measures
hernia recurrence
postoperative seroma formation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01860469
Brief Title
Reducing Mesh Infections in Open Hernia Repairs
Official Title
Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Open Hernia Repair, Patients Undergoing Ventral or Inguinal Hernia Repair
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
plain mesh
Arm Type
Active Comparator
Arm Description
standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair
Arm Title
vancomycin-soaked mesh
Arm Type
Experimental
Arm Description
use of vancomycin-soaked mesh for open hernia repair
Intervention Type
Procedure
Intervention Name(s)
vancomycin-soaked mesh
Intervention Type
Procedure
Intervention Name(s)
plain mesh
Other Intervention Name(s)
non vancomycin-soaked mesh
Primary Outcome Measure Information:
Title
mesh infections
Time Frame
6 months
Secondary Outcome Measure Information:
Title
hernia recurrence
Time Frame
6 months
Title
postoperative seroma formation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
open ventral or inguinal hernia repair
Exclusion Criteria:
laparoscopic hernia repair
non ventral or inguinal hernia repairs
Facility Information:
Facility Name
Five Hills Health Region
City
Moose Jaw
State/Province
Saskatchewan
ZIP/Postal Code
S6H 1H3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Cadili, MD, FRCSC
Phone
3066940200
Email
alicadili1@gmail.com
First Name & Middle Initial & Last Name & Degree
Ali Cadili, MD, FRCSc
First Name & Middle Initial & Last Name & Degree
Nishaan Cheddie, MD, FRCSc
First Name & Middle Initial & Last Name & Degree
George B Miller, MD, FRCSc
12. IPD Sharing Statement
Learn more about this trial
Reducing Mesh Infections in Open Hernia Repairs
We'll reach out to this number within 24 hrs