Status:

COMPLETED

Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair

Lead Sponsor:

McMaster University

Conditions:

Ventral Hernia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial wi...

Detailed Description

This study is a multicentre, clinical randomized controlled trial comparing the use of incisional negative pressure wound therapy versus standard sterile dressings in high-risk ventral hernia repairs....

Eligibility Criteria

Inclusion

  • patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter
  • have one or more of the following risk factors for post-operative surgical site complications:
  • Body Mass Index (BMI) greater than or equal to 30
  • diagnosis of diabetes mellitus (either type I or II)
  • previous history of hernia recurrence
  • active smoker
  • presence of colostomy or ileostomy
  • age greater than 64
  • chronic obstructive pulmonary disease
  • chronic kidney disease
  • clinically immunocompromised.

Exclusion

  • the abdomen is left open post-operatively, or
  • if the patient has a sensitivity to silver.

Key Trial Info

Start Date :

December 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2024

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT04455724

Start Date

December 14 2020

End Date

May 1 2024

Last Update

June 27 2024

Active Locations (1)

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1

Niagara Health St. Catharines Site

St. Catharines, Ontario, Canada, L2R 2A8