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Wound Therapy

Vacuum Dressings for Ventral Hernia Repair (N-PITH Trial)

N/A

Recruiting

Led By Christopher E Blewett, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

clinically immunocompromised.

- Chronic kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-operatively

Awards & highlights

N-PITH Trial Summary

This trial is testing whether vacuum dressings can help improve wound healing for patients who are at risk of wound complications from large hernia surgery.

Who is the study for?

This trial is for adults over 64 with large hernias (over 3 cm), a BMI of 30 or more, diabetes, kidney disease, history of hernia recurrence, smokers, those with colostomy/ileostomy or COPD. It's not for patients whose abdomen is left open after surgery or who are allergic to silver.Check my eligibility

What is being tested?

The study compares the effectiveness of vacuum dressings versus standard sterile dressings in enhancing wound healing post-ventral hernia repair surgery in high-risk patients. Participants will be randomly assigned one of the two dressing types and monitored during hospital stay and follow-ups.See study design

What are the potential side effects?

While specific side effects aren't listed for this trial, potential risks may include skin irritation from the dressings, infection at the wound site, pain or discomfort associated with negative pressure therapy.

N-PITH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a weakened immune system.

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I have chronic kidney disease.

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I have a colostomy or ileostomy.

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I have chronic obstructive pulmonary disease.

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I am 65 years old or older.

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I am 65 years old or older.

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I have had a hernia come back after treatment.

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I have had a hernia come back after treatment.

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I have a colostomy or ileostomy.

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I have been diagnosed with diabetes (type 1 or 2).

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I have chronic obstructive pulmonary disease.

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I have chronic kidney disease.

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I have been diagnosed with diabetes.

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I am having surgery for a hernia larger than 3 cm.

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I am having surgery for a hernia larger than 3 cm.

N-PITH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical Site Complications

Secondary outcome measures

Cost-effectiveness

Quality of life after surgery: survey

N-PITH Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Negative Pressure Incisional Wound TherapyExperimental Treatment1 Intervention

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.

Group II: Standard sterile dressingActive Control1 Intervention

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.

0 / 15Eligibility criteria met