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Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction

This study is currently recruiting participants.
Verified January 2017 by Janis, Jeffrey E, MD, The Ohio State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02228889
First Posted: August 29, 2014
Last Update Posted: January 18, 2017
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.
Information provided by (Responsible Party):
Janis, Jeffrey E, MD, The Ohio State University
August 18, 2014
August 29, 2014
January 18, 2017
January 2015
November 2018   (Final data collection date for primary outcome measure)
Overall complication rate at 1 year [ Time Frame: 1 year postoperatively ]
Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively
Same as current
Complete list of historical versions of study NCT02228889 on ClinicalTrials.gov Archive Site
  • Rate of Surgical Site Occurrences (SSOs) at 1 year [ Time Frame: 1 year postoperatively ]

    Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:

    1. Infection
    2. Seroma
    3. Hematoma
    4. Wound dehiscence
    5. Skin necrosis
    6. Formation of enterocutaneous fistula
    7. Mesh infection
  • Hernia recurrence rate at 30 days [ Time Frame: 30 days postoperatively ]
  • Bulge rate at 30 days [ Time Frame: 30 days postoperatively ]
  • Overall complication rate at 30 days [ Time Frame: 30 days postoperatively ]
    Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively
  • Rate of Surgical Site Occurrences (SSOs) at 30 days [ Time Frame: 30 days postoperatively ]

    Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include:

    1. Infection
    2. Seroma
    3. Hematoma
    4. Wound dehiscence
    5. Skin necrosis
    6. Formation of enterocutaneous fistula
    7. Mesh infection
  • Hernia recurrence rate at 1 year [ Time Frame: 1 year postoperatively ]
  • Bulge rate at 1 year [ Time Frame: 1 year postoperatively ]
  • Pain intensity preoperatively [ Time Frame: At the last office visit before surgery (average of 1-3 weeks before surgery) ]
    Measure patient pain intensity of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Intensity survey
  • Pain interference preoperatively [ Time Frame: At the last office visit before surgery (average of 1-3 weeks before surgery) ]
    Measure patient pain interference of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Interference survey
  • Pain intensity postoperatively [ Time Frame: 1 year postoperatively ]
    Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey
  • Pain interference postoperatively [ Time Frame: 1 year postoperatively ]
    Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey
  • Physical functioning preoperatively [ Time Frame: At the last office visit before surgery (average of 1-3 weeks before surgery) ]
    Measure physical functioning of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Physical Function survey
  • Physical functioning postoperatively [ Time Frame: 1 year postoperatively ]
    Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey
  • Quality of life preoperatively [ Time Frame: At the last office visit before surgery (average of 1-3 weeks before surgery) ]
    Measure patient quality of life of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the HerQLes survey (Hernia Related Quality of Life survey)
  • Quality of life postoperatively [ Time Frame: 1 year postoperatively ]
    Measure patient quality of life of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the HerQLes survey (Hernia Related Quality of Life survey)
Same as current
Not Provided
Not Provided
 
Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
Not Provided
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).

Our goals in this study are:

  1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
  2. SECONDARY OUTCOMES

i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively

  1. Infection
  2. Seroma
  3. Hematoma
  4. Wound dehiscence
  5. Skin necrosis
  6. Formation of enterocutaneous fistula
  7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Hernia, Ventral
  • Intestinal Fistula
  • Fibromatosis, Abdominal
  • Procedure: Abdominal wall reconstruction with Strattice
    Abdominal wall reconstruction using Strattice
  • Other: Assess pain intensity at last office visit preoperatively
    Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
  • Other: Assess pain interference at last office visit preoperatively
    Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
  • Other: Assess physical functioning at last office visit preoperatively
    Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
  • Other: Assess patient quality of life at last office visit preoperatively
    Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
  • Other: Assess patient pain intensity postoperatively
    Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
  • Other: Assess pain interference postoperatively
    Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
  • Other: Assess physical functioning postoperatively
    Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
  • Other: Assess quality of life postoperatively
    Assess quality of life at 1 year postoperatively using the HerQLes survey
  • Other: Assess hernia recurrence at 30 days postoperatively
    Assess hernia recurrence at 30 days
  • Other: Assess bulge at 30 days postoperatively
    Assess bulge at 30 days
  • Other: Assess Surgical Site Occurrences at 30 days postoperatively
    Assess Surgical Site Occurrences at 30 days
  • Other: Assess hernia recurrence at 1 year postoperatively
    Assess hernia recurrence at 1 year postoperatively
  • Other: Assess bulge at 1 year postoperatively
    Assess bulge at 1 year postoperatively
  • Other: Assess Surgical Site Occurrences at 1 year postoperatively
    Assess Surgical Site Occurrences at 1 year postoperatively
  • Other: Assess overall complications at 30 days postoperatively
  • Other: Assess overall complications at 1 year postoperatively
  • Procedure: Abdominal wall reconstruction with XenMatrix
    Abdominal wall reconstruction with XenMatrix
  • Device: Strattice
    Strattice mesh
  • Device: XenMatrix
    Xenmatrix mesh
  • Experimental: Strattice
    Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
    Interventions:
    • Procedure: Abdominal wall reconstruction with Strattice
    • Other: Assess pain intensity at last office visit preoperatively
    • Other: Assess pain interference at last office visit preoperatively
    • Other: Assess physical functioning at last office visit preoperatively
    • Other: Assess patient quality of life at last office visit preoperatively
    • Other: Assess patient pain intensity postoperatively
    • Other: Assess pain interference postoperatively
    • Other: Assess physical functioning postoperatively
    • Other: Assess quality of life postoperatively
    • Other: Assess hernia recurrence at 30 days postoperatively
    • Other: Assess bulge at 30 days postoperatively
    • Other: Assess Surgical Site Occurrences at 30 days postoperatively
    • Other: Assess hernia recurrence at 1 year postoperatively
    • Other: Assess bulge at 1 year postoperatively
    • Other: Assess Surgical Site Occurrences at 1 year postoperatively
    • Other: Assess overall complications at 30 days postoperatively
    • Other: Assess overall complications at 1 year postoperatively
    • Device: Strattice
  • Experimental: XenMatrix
    Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
    Interventions:
    • Other: Assess pain intensity at last office visit preoperatively
    • Other: Assess pain interference at last office visit preoperatively
    • Other: Assess physical functioning at last office visit preoperatively
    • Other: Assess patient quality of life at last office visit preoperatively
    • Other: Assess patient pain intensity postoperatively
    • Other: Assess pain interference postoperatively
    • Other: Assess physical functioning postoperatively
    • Other: Assess quality of life postoperatively
    • Other: Assess hernia recurrence at 30 days postoperatively
    • Other: Assess bulge at 30 days postoperatively
    • Other: Assess Surgical Site Occurrences at 30 days postoperatively
    • Other: Assess hernia recurrence at 1 year postoperatively
    • Other: Assess bulge at 1 year postoperatively
    • Other: Assess Surgical Site Occurrences at 1 year postoperatively
    • Other: Assess overall complications at 30 days postoperatively
    • Other: Assess overall complications at 1 year postoperatively
    • Procedure: Abdominal wall reconstruction with XenMatrix
    • Device: XenMatrix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
November 2018
November 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
  • Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
  • Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).

Exclusion Criteria:

  • Known allergy to porcine products
  • Active smokers (within the past 4 weeks) presenting for elective hernia repair
  • Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
  • Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
  • Patients with severe systemic sepsis
  • Patients with frank purulence in the wound
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact: Ibrahim Z Khansa, MD 614-293-9030 ibrahim.khansa@gmail.com
Contact: Jeffrey E Janis, MD 614-366-1704 jeffrey.janis@osumc.edu
United States
 
 
NCT02228889
2014H0041
No
Not Provided
Not Provided
Janis, Jeffrey E, MD, The Ohio State University
Janis, Jeffrey E, MD
Not Provided
Principal Investigator: Jeffrey E Janis, MD Ohio State University
Ohio State University
January 2017

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