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

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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

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 2, 2020
Last Update Posted Date March 17, 2023
Actual Study Start Date  ICMJE December 14, 2020
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair
Official Title  ICMJE Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Ventral Hernia
Intervention  ICMJE
  • 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.
  • Device: Standard sterile dressing
    A standard, sterile island dressing
Study Arms  ICMJE
  • 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.
    Intervention: Device: Negative pressure incisional wound therapy
  • 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.
    Intervention: Device: Standard sterile dressing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2020)		 110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nathan E How, MD 613-539-1337 nathan.how@medportal.ca
Contact: Christopher Blewett, MD 289 606 1333 blewettc@gmail.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04455724
Other Study ID Numbers  ICMJE 8183
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party McMaster University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE McMaster University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher E Blewett, MD McMaster University
PRS Account McMaster University
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP