Back to resultsComparative Study of Biologic Mesh Versus Repair With Component Separation. (Davol)
Primary Purpose
Ventral Hernia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XenMATRIX mesh
Open abdominal ventral hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring Infected ventral hernia, Contaminated incisional hernia
Eligibility Criteria
Inclusion Criteria:
- Is an adult ≥ 18 years old of either gender
- Will undergo a planned open abdominal incisional hernia repair
- Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
- Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
- Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
- Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
- Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
- Is willing and able to return for all scheduled and required study visits
- Is willing and able to provide written informed consent for study participation
Exclusion Criteria:
- Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
- Is a clean or dirty case per Surgical Site Infection Risk Guidelines
- Has conditions that would adversely affect subject safety as per product labeling
- Will undergo a laparoscopic hernia repair
- Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
- Has conditions which preclude abdominal imaging at a standard imaging facility
- Has an anticipated survival of < 24 months
- Care plan is to perform a staged repair over 45 days
- Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
- Is ASA class 4 or 5
- BMI over 45
- Is pregnant
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
XenMATRIX
Arm Description
Use of XenMATRIX mesh to repair hernia
Outcomes
Primary Outcome Measures
The Incidence of Postoperative Hernia Recurrence
Secondary Outcome Measures
Compare the Short-term Clinical Outcomes of Postoperative Wound Events
Length of Hospital Stay
Participants will be followed for the duration of the hospital stay, an expected average of 1 week
Length of Resource Utilization
Antibiotic Usage and Days
Resumption of Activities of Daily Living
Full Information
NCT ID
NCT01295125
First Posted
February 11, 2011
Last Updated
January 3, 2023
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Bard Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01295125
Brief Title
Comparative Study of Biologic Mesh Versus Repair With Component Separation.
Acronym
Davol
Official Title
Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor chose not to move forward with study
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Bard Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.
Detailed Description
This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue.
The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects.
This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
Infected ventral hernia, Contaminated incisional hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XenMATRIX
Arm Type
Experimental
Arm Description
Use of XenMATRIX mesh to repair hernia
Intervention Type
Device
Intervention Name(s)
XenMATRIX mesh
Other Intervention Name(s)
Davol Biologic mesh
Intervention Description
Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
Intervention Type
Procedure
Intervention Name(s)
Open abdominal ventral hernia repair
Other Intervention Name(s)
Abdominal ventral hernia repair with native tissue
Intervention Description
Abdominal ventral hernia repair with native tissue
Primary Outcome Measure Information:
Title
The Incidence of Postoperative Hernia Recurrence
Time Frame
two years after surgery date
Secondary Outcome Measure Information:
Title
Compare the Short-term Clinical Outcomes of Postoperative Wound Events
Time Frame
two years after surgery date
Title
Length of Hospital Stay
Description
Participants will be followed for the duration of the hospital stay, an expected average of 1 week
Time Frame
Number of days up to 1 week
Title
Length of Resource Utilization
Time Frame
two years after surgery date
Title
Antibiotic Usage and Days
Time Frame
two years after surgery date
Title
Resumption of Activities of Daily Living
Time Frame
two years after surgery date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is an adult ≥ 18 years old of either gender
Will undergo a planned open abdominal incisional hernia repair
Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
Is willing and able to return for all scheduled and required study visits
Is willing and able to provide written informed consent for study participation
Exclusion Criteria:
Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
Is a clean or dirty case per Surgical Site Infection Risk Guidelines
Has conditions that would adversely affect subject safety as per product labeling
Will undergo a laparoscopic hernia repair
Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
Has conditions which preclude abdominal imaging at a standard imaging facility
Has an anticipated survival of < 24 months
Care plan is to perform a staged repair over 45 days
Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
Is ASA class 4 or 5
BMI over 45
Is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Rosen, MD.
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Biologic Mesh Versus Repair With Component Separation.
We'll reach out to this number within 24 hrs