Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair (N-PITH)

McMaster University

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Standard sterile dressing; Device: Negative pressure incisional wound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04455724

8183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Negative Pressure Incisional Wound Therapy

Experimental group

Description:

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.

Treatment:

Device: Negative pressure incisional wound therapy

Standard sterile dressing

Active Comparator group

Description:

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.

Treatment:

Device: Standard sterile dressing