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

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ClinicalTrials.gov Identifier: NCT02228889
Recruitment Status : Recruiting
First Posted : August 29, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey E Janis, MD, The Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hernia, Ventral Intestinal Fistula Fibromatosis, Abdominal 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 Procedure: Abdominal wall reconstruction with XenMatrix Device: Strattice Device: XenMatrix Phase 4

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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 Device: Strattice
Strattice mesh
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
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: XenMatrix
Xenmatrix mesh



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Hernia recurrence rate at 30 days [ Time Frame: 30 days postoperatively ]
  3. Bulge rate at 30 days [ Time Frame: 30 days postoperatively ]
  4. 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

  5. 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

  6. Hernia recurrence rate at 1 year [ Time Frame: 1 year postoperatively ]
  7. Bulge rate at 1 year [ Time Frame: 1 year postoperatively ]
  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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)

  15. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02228889


Contacts
Contact: Ibrahim Z Khansa, MD 614-293-9030 ibrahim.khansa@gmail.com
Contact: Jeffrey E Janis, MD 614-366-1704 jeffrey.janis@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Jeffrey E Janis, MD         
Sub-Investigator: Ibrahim Z Khansa, MD         
Sub-Investigator: Daniel S Eiferman, MD         
Sub-Investigator: Steven Steinberg, MD         
Sub-Investigator: Vimal Narula, MD         
Sponsors and Collaborators
Jeffrey E Janis, MD
Investigators
Principal Investigator: Jeffrey E Janis, MD Ohio State University

Responsible Party: Jeffrey E Janis, MD, Professor of Plastic Surgery, Vice-Chairman, The Ohio State University
ClinicalTrials.gov Identifier: NCT02228889     History of Changes
Other Study ID Numbers: 2014H0041
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Jeffrey E Janis, MD, The Ohio State University:
Hernia
Abdominal wall reconstruction
Abdominal wall defect
Porcine mesh
Component separation
Abdominal wall tumor
Desmoid

Additional relevant MeSH terms:
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Hernia
Fistula
Fibroma
Hernia, Ventral
Intestinal Fistula
Fibromatosis, Abdominal
Pathological Conditions, Anatomical
Hernia, Abdominal
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases