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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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.

Detailed Summary:

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

Sponsor: Janis, Jeffrey E, MD

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: August 18, 2014
Date Started: January 2015
Date Completion: November 2018
Last Updated: January 14, 2017
Last Verified: January 2017