Ventral HerniaNCT01794338
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
A study testing Strattice Arm and Bio-A Arm in people with Ventral Hernia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Strattice Arm and Bio-A Arm
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 21 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
- Pre-operative informed consent is obtainable
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28204
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Strattice Arm, Bio-A Arm
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattice ArmDevice
Biologic mesh to be placed during hernia repair surgery
Bio-A ArmDevice
Bioabsorbable mesh to be placed during hernia repair surgery
| Study group | Role | What they receive |
|---|---|---|
| Bio-A Arm | Experimental | 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. Receives: Device: Bio-A Arm |
| Strattice Arm | Active comparator | 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.. Receives: Device: Strattice Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2017
- Study completion21 Jul 2017
Why it stopped: Lack of incorporation with patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brant T Heniford, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794338
- Sponsor's protocol ID
- 09-12-02A
- Status last verified
- Apr 2022
- First submitted
- 15 Feb 2013
- Last updated
- 15 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01794338
- Acronym / sponsor ID
- 09-12-02A
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of incorporation with patients
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Posted 3 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-A Arm | Experimental | Device: Bio-A ArmPatients 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. |
| Strattice Arm | Active comparator | Device: Strattice ArmPatients 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.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
- Pre-operative informed consent is obtainable
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strattice ArmBiologic mesh to be placed during hernia repair surgery | Device | Strattice Arm |
| Bio-A ArmBioabsorbable mesh to be placed during hernia repair surgery | Device | Bio-A Arm |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brant T Heniford, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strattice Arm and Bio-A Arm in people with Ventral Hernia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.