Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair
NCT04455724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2024-06-27
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 will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.
Conditions
- Ventral Hernia
Interventions
- DEVICE
-
Negative pressure incisional wound therapy
A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
- DEVICE
-
Standard sterile dressing
A standard, sterile island dressing
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Christopher E Blewett, MD · McMaster University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-12-14
- Primary Completion
- 2024-05-01
- Completion
- 2024-05-01
- FDA Device
- Yes
Countries
- Canada
Study Locations
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