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RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

Primary Purpose

Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
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
Abdominal wall reconstruction with XenMatrix
Strattice
XenMatrix
Sponsored by
Jeffrey Janis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring Hernia, Abdominal wall reconstruction, Abdominal wall defect, Porcine mesh, Component separation, Abdominal wall tumor, Desmoid

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Strattice

XenMatrix

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall complication rate at 1 year
Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively

Secondary Outcome Measures

Rate of Surgical Site Occurrences (SSOs) at 1 year
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: Infection Seroma Hematoma Wound dehiscence Skin necrosis Formation of enterocutaneous fistula Mesh infection
Hernia recurrence rate at 30 days
Bulge rate at 30 days
Overall complication rate at 30 days
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
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include: Infection Seroma Hematoma Wound dehiscence Skin necrosis Formation of enterocutaneous fistula Mesh infection
Hernia recurrence rate at 1 year
Bulge rate at 1 year
Pain intensity preoperatively
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
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
Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey
Pain interference 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
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
Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey
Quality of life preoperatively
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
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)

Full Information

First Posted
August 18, 2014
Last Updated
September 21, 2022
Sponsor
Jeffrey Janis
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1. Study Identification

Unique Protocol Identification Number
NCT02228889
Brief Title
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Official Title
Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey Janis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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: 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 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 Infection Seroma Hematoma Wound dehiscence Skin necrosis Formation of enterocutaneous fistula 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal
Keywords
Hernia, Abdominal wall reconstruction, Abdominal wall defect, Porcine mesh, Component separation, Abdominal wall tumor, Desmoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Abdominal wall reconstruction using Strattice
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strattice
Arm Type
Experimental
Arm Description
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
Arm Title
XenMatrix
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Abdominal wall reconstruction with Strattice
Intervention Description
Abdominal wall reconstruction using Strattice
Intervention Type
Other
Intervention Name(s)
Assess pain intensity at last office visit preoperatively
Intervention Description
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Intervention Type
Other
Intervention Name(s)
Assess pain interference at last office visit preoperatively
Intervention Description
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Intervention Type
Other
Intervention Name(s)
Assess physical functioning at last office visit preoperatively
Intervention Description
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Intervention Type
Other
Intervention Name(s)
Assess patient quality of life at last office visit preoperatively
Intervention Description
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Intervention Type
Other
Intervention Name(s)
Assess patient pain intensity postoperatively
Intervention Description
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Intervention Type
Other
Intervention Name(s)
Assess pain interference postoperatively
Intervention Description
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Intervention Type
Other
Intervention Name(s)
Assess physical functioning postoperatively
Intervention Description
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Intervention Type
Other
Intervention Name(s)
Assess quality of life postoperatively
Intervention Description
Assess quality of life at 1 year postoperatively using the HerQLes survey
Intervention Type
Other
Intervention Name(s)
Assess hernia recurrence at 30 days postoperatively
Intervention Description
Assess hernia recurrence at 30 days
Intervention Type
Other
Intervention Name(s)
Assess bulge at 30 days postoperatively
Intervention Description
Assess bulge at 30 days
Intervention Type
Other
Intervention Name(s)
Assess Surgical Site Occurrences at 30 days postoperatively
Intervention Description
Assess Surgical Site Occurrences at 30 days
Intervention Type
Other
Intervention Name(s)
Assess hernia recurrence at 1 year postoperatively
Intervention Description
Assess hernia recurrence at 1 year postoperatively
Intervention Type
Other
Intervention Name(s)
Assess bulge at 1 year postoperatively
Intervention Description
Assess bulge at 1 year postoperatively
Intervention Type
Other
Intervention Name(s)
Assess Surgical Site Occurrences at 1 year postoperatively
Intervention Description
Assess Surgical Site Occurrences at 1 year postoperatively
Intervention Type
Other
Intervention Name(s)
Assess overall complications at 30 days postoperatively
Intervention Type
Other
Intervention Name(s)
Assess overall complications at 1 year postoperatively
Intervention Type
Procedure
Intervention Name(s)
Abdominal wall reconstruction with XenMatrix
Intervention Description
Abdominal wall reconstruction with XenMatrix
Intervention Type
Device
Intervention Name(s)
Strattice
Intervention Description
Strattice mesh
Intervention Type
Device
Intervention Name(s)
XenMatrix
Intervention Description
Xenmatrix mesh
Primary Outcome Measure Information:
Title
Overall complication rate at 1 year
Description
Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively
Time Frame
1 year postoperatively
Secondary Outcome Measure Information:
Title
Rate of Surgical Site Occurrences (SSOs) at 1 year
Description
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: Infection Seroma Hematoma Wound dehiscence Skin necrosis Formation of enterocutaneous fistula Mesh infection
Time Frame
1 year postoperatively
Title
Hernia recurrence rate at 30 days
Time Frame
30 days postoperatively
Title
Bulge rate at 30 days
Time Frame
30 days postoperatively
Title
Overall complication rate at 30 days
Description
Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively
Time Frame
30 days postoperatively
Title
Rate of Surgical Site Occurrences (SSOs) at 30 days
Description
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include: Infection Seroma Hematoma Wound dehiscence Skin necrosis Formation of enterocutaneous fistula Mesh infection
Time Frame
30 days postoperatively
Title
Hernia recurrence rate at 1 year
Time Frame
1 year postoperatively
Title
Bulge rate at 1 year
Time Frame
1 year postoperatively
Title
Pain intensity preoperatively
Description
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
Time Frame
At the last office visit before surgery (average of 1-3 weeks before surgery)
Title
Pain interference preoperatively
Description
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
Time Frame
At the last office visit before surgery (average of 1-3 weeks before surgery)
Title
Pain intensity postoperatively
Description
Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey
Time Frame
1 year postoperatively
Title
Pain interference postoperatively
Description
Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey
Time Frame
1 year postoperatively
Title
Physical functioning preoperatively
Description
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
Time Frame
At the last office visit before surgery (average of 1-3 weeks before surgery)
Title
Physical functioning postoperatively
Description
Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey
Time Frame
1 year postoperatively
Title
Quality of life preoperatively
Description
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)
Time Frame
At the last office visit before surgery (average of 1-3 weeks before surgery)
Title
Quality of life postoperatively
Description
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)
Time Frame
1 year postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Z Khansa, MD
Phone
614-293-9030
Email
ibrahim.khansa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey E Janis, MD
Phone
614-366-1704
Email
jeffrey.janis@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey E Janis, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey E Janis, MD
First Name & Middle Initial & Last Name & Degree
Ibrahim Z Khansa, MD
First Name & Middle Initial & Last Name & Degree
Daniel S Eiferman, MD
First Name & Middle Initial & Last Name & Degree
Vimal Narula, MD

12. IPD Sharing Statement

Learn more about this trial

RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

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