Reducing Mesh Infections in Open Hernia Repairs

Patients Undergoing Open Hernia Repair Clinical Trial

Official title:

Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01860469
• Other study ID #: MeshVanco
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: May 18, 2013
• Last updated: May 18, 2013
• Start date: June 2013

Study information

• Verified date: May 2013
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• open ventral or inguinal hernia repair

Exclusion Criteria:

• laparoscopic hernia repair

• non ventral or inguinal hernia repairs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Procedure:
• vancomycin-soaked mesh

• plain mesh

Locations

Country	Name	City	State
Canada	Five Hills Health Region	Moose Jaw	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mesh infections		6 months	Yes
Secondary	hernia recurrence		6 months	Yes
Secondary	postoperative seroma formation		6 months	No