Reducing Mesh Infections in Open Hernia Repairs | NCT01860469

Studies
Reducing Mesh Infections in Open Hernia Repairs

NCT01860469

Sponsor

University of Saskatchewan

Status

Unknown status

Last Update Posted

May 22, 2013Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Patients Undergoing Open Hernia Repair
Patients Undergoing Ventral or Inguinal Hernia Repair

Interventions

vancomycin-soaked mesh
plain mesh

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Not provided

First Submitted Date

May 18, 2013

First Submission Date that Met QC Criteria

May 18, 2013

First Posted Date

May 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2013

Last Update Posted Date

May 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
plain mesh	Active Comparator	standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair	Procedure: plain mesh
vancomycin-soaked mesh	Experimental	use of vancomycin-soaked mesh for open hernia repair	Procedure: vancomycin-soaked mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vancomycin-soaked mesh	Procedure		vancomycin-soaked mesh
plain mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mesh infections		6 months

Secondary Outcomes

Measure	Description	Time Frame
hernia recurrence		6 months
postoperative seroma formation		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

open ventral or inguinal hernia repair

Exclusion Criteria:

laparoscopic hernia repair
non ventral or inguinal hernia repairs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Five Hills Health Region		Moose Jaw	Saskatchewan	S6H 1H3	Canada