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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Negative pressure incisional wound therapy
* Device: Standard sterile dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: the abdomen is left open post-operatively, or if the patient has a sensitivity to silver.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Incisional Wound Therapy<br>A PREVENA™ PEEL & PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site. | Device: Negative pressure incisional wound therapy<br>* A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.<br>|
| Active Comparator: Standard sterile dressing<br>A sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge. | Device: Standard sterile dressing<br>* A standard, sterile island dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Complications | Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation. | First 3 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life after surgery: survey | Quality of life as measured using the Hernia-Related Quality of Life Survey (HerQLes). Scoring is out of 100, with higher scores indicating better quality of life. | 3 months post-operatively | 
| Cost-effectiveness | Cost in dollars per quality-adjusted life year, measured using hospital length of stay, cost of complications, and cost of intervention | 3 months post-operatively |