Clinical trial NCT04455724: Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair
Official title: Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Site Complications
timeFrame: First 3 months post-operatively
Secondary outcomes:
measure: Quality of life after surgery: survey
timeFrame: 3 months post-operatively
measure: Cost-effectiveness
timeFrame: 3 months post-operatively
Other outcomes:
Locations:
city: St. Catharines
country: Canada
facility: Niagara Health St. Catharines Site
state: Ontario
Study officials:
affiliation: McMaster University
name: Christopher E Blewett, MD
role: PRINCIPAL_INVESTIGATOR
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