NCT04455724

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

Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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. The trial will be enrolling patients undergoing elective or emergent ventral hernia repair who have risk factors for surgical wound complications and randomizing them to either receive a PREVENA incisional negative pressure wound therapy system dressing for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The primary outcome will be a composite of a variety of surgical site complications including wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will include perceived difference in Quality of Life and cost-effectiveness of the intervention.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-14
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2020-07-02
• Last updated: 2024-06-27

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study