- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794338
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
August 11, 2022 updated by: Wake Forest University Health Sciences
A Randomized, Prospective, Double Blind Clinical Trial of Non-cross-linked Porcine Dermis vs. Bioabsorbable Synthetic Mesh for the Repair of Abdominal Wall Defects in At-risk Patients
This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias.
The purpose of this study is to collect information and evaluate the outcome of your surgery.
Synthetic (man made) mesh has been shown to provide durable long-term outcomes; however, this type of mesh should not be used in patients at risk of developing an infection.
Therefore, to address the challenge of finding an artificial strengthening material to repair complicated hernias in patients that could potentially develop surgical infection, two types of non-permanent materials have been developed, including biologics and bioabsorbables.
Biologic mesh is made of living tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the body over time.
The purpose of this study is to allow surgeons to compare the postoperative course of patients associated with these two mesh types to decide which material will improve the outcomes of their patients with complicated abdominal wall defects.
To date there is no evidence to suggest that either mesh type is superior or safer than the other.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The goal of the proposed study is to evaluate the outcomes of patients implanted with Strattice® (LifeCell Corporation, Branchburg, NJ, USA) and Gore® Bio-A® (W.
L. Gore & Associates, Inc., Newark, DE, USA) for the repair of abdominal wall defects in at-risk patients.
Primary endpoints of the study will include hernia recurrence, duration of postoperative drains, the incidence of systemic and wound-related complications, the need for percutaneous intervention or reoperation and quality- of-life with 3 years of follow-up.
The study will be prospective and randomized, and the evaluator and patient will be blinded as to the type of mesh implanted.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Atrium Health - Carolinas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or older
- Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
- Pre-operative informed consent is obtainable
Exclusion Criteria:
- Return to the operating room within the next 1 year for additional open abdominal surgery is anticipated
- Absence of fascial defect or fascial defect less than 3 cm in greatest dimension
- Presence of previously place mesh (synthetic or biologic) at the site of surgery, which will not be completely removed and will, in part or whole, remain at the site of implantation of the study mesh
- Concurrent placement of another mesh (synthetic or biologic) at the site where the study mesh is placed
- Grade IV ventral hernia according to VHWG system
- ASA score IV or above
- Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of either study mesh
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bio-A Arm
Patients will receive underlay mesh tissue reinforcement followed by standard fascial closure with #1 PDS.
As described by Dr. Stoppa10-12, the mesh will be secured via abdominal wall sutures.
Additional full thickness sutures will be placed every 8 cm circumferentially.
After securing the mesh in place, #1 PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm "bites" from the fascial edge and a 1cm "walk" between stitches.
Skin will be closed with staples or monofilament suture according to surgeon preference.
Drains will be placed on the mesh in each case, and one or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on the amount of subcutaneous tissue dissected.
|
Bioabsorbable mesh to be placed during hernia repair surgery
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ACTIVE_COMPARATOR: Strattice Arm
Patients will receive underlay mesh tissue reinforcement followed by standard fascial closure with #1 PDS.
As described by Dr. Stoppa10-12, the mesh will be secured via abdominal wall sutures.
Additional full thickness sutures will be placed every 8 cm circumferentially.
After securing the mesh in place, #1 PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm "bites" from the fascial edge and a 1cm "walk" between stitches.
Skin will be closed with staples or monofilament suture according to surgeon preference.
Drains will be placed on the mesh in each case, and one or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on the amount of subcutaneous tissue dissected..
|
Biologic mesh to be placed during hernia repair surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hernia Recurrence
Time Frame: 3 years
|
Patients will undergo post-operative follow-up at 1 month, 6 months, and yearly for 3 years.
Patients will receive reminders of their follow-up visits before each time period.
At each visit, patients will be asked to fill out a short questionnaire (Form A and Form B) that will aid in assessing and documenting postoperative symptoms and quality of life.
During each follow-up visit a board certified or board eligible surgeon, who is blinded with regard to the group assignment, will perform a physical examination to assess for the presence of a recurrent hernia, eventration and other findings detailed on Form C. Any signs of wound complications will be noted, including seroma formation, erythema, drainage, break in the skin, purulence or tenderness to palpation.
If a recurrent hernia defect is identified on the physical examination, imaging studies will be performed as indicated.
Once a hernia defect is found, further management options will be discussed with the patient.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
July 1, 2017
Study Completion (ACTUAL)
July 21, 2017
Study Registration Dates
First Submitted
February 15, 2013
First Submitted That Met QC Criteria
February 15, 2013
First Posted (ESTIMATE)
February 18, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 15, 2022
Last Update Submitted That Met QC Criteria
August 11, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-12-02A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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