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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455724
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Device: Negative pressure incisional wound therapy Device: Standard sterile dressing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Given the physical differences in the negative pressure wound therapy systems compared to standard sterile dressings, patient participants and care providers will not be able to be blinded. Ultrasound evaluators and statisticians, however, will be.
Primary Purpose: Treatment
Official Title: Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Negative pressure incisional wound therapy
A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
Active Comparator: 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.
 Device: Standard sterile dressing
A standard, sterile island dressing


Outcome Measures
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Primary Outcome Measures :
  1. Surgical Site Complications [ Time Frame: 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 :
  1. Quality of life after surgery: survey [ Time Frame: 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.

  2. Cost-effectiveness [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455724


Contacts
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Contact: Nathan E How, MD 613-539-1337 nathan.how@medportal.ca
Contact: Christopher Blewett, MD 289 606 1333 blewettc@gmail.com

Locations
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Canada, Ontario
Niagara Health St. Catharines Site Recruiting
St. Catharines, Ontario, Canada, L2R 2A8
Contact: Nathan How, MD         
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Christopher E Blewett, MD McMaster University
More Information
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Publications:

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04455724    
Other Study ID Numbers: 8183
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal