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

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Device: Negative pressure incisional wound therapy; Device: Standard sterile dressing

• Registration Number: NCT04455724
• Lead Sponsor: McMaster University

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 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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Study Start: 2020-12-14
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter

2. have one or more of the following risk factors for post-operative surgical site complications:

   1. Body Mass Index (BMI) greater than or equal to 30
   2. diagnosis of diabetes mellitus (either type I or II)
   3. previous history of hernia recurrence
   4. active smoker
   5. presence of colostomy or ileostomy
   6. age greater than 64
   7. chronic obstructive pulmonary disease
   8. chronic kidney disease
   9. clinically immunocompromised.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Incisional Wound Therapy	Negative pressure incisional wound therapy	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.
Standard sterile dressing	Standard sterile dressing	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.

Primary Outcome Measures

Name	Time	Method
Surgical Site Complications	First 3 months post-operatively	Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.

Secondary Outcome Measures

Name	Time	Method
Quality of life after surgery: survey	3 months post-operatively	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.
Cost-effectiveness	3 months post-operatively	Cost in dollars per quality-adjusted life year, measured using hospital length of stay, cost of complications, and cost of intervention

Trial Locations

Locations (1)

Niagara Health St. Catharines Site; 🇨🇦 St. Catharines, Ontario, Canada