Ventral HerniaPhase 4RAM2PNCT00930787
Hernia Repair in Multiply Morbid Patients
A Phase 4 study testing Strattice Reconstructive Tissue Matrix (Hernia Repair) and Proceed Surgical Mesh (Hernia repair) in people with Ventral Hernia, run by LifeCell at 13 sites in United States.
Trial summary
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are… 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 Reconstructive Tissue Matrix (Hernia Repair) and Proceed Surgical Mesh (Hernia repair)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2009to May 2010
- Phase
- Phase 4
- 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
- Adults of either gender
- must have 2 or more co-morbidities
Who cannot join
- local or systemic infection
- expected survival of <24 months
- non-ambulatory
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Maryland
Baltimore, Maryland, 21201
University Hospital - Case Western
Cleveland, Ohio, 44106
Hurley Medical Center
Flint, Michigan, 48503
University of Texas - MD Anderson Cancer Center
Houston, Texas, 70115
Truman Medical Center
Kansas City, Missouri, 64108
Long Island Jewish - North Shore
Lake Success, New York, 11042
Louisiana Status University Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University
New Orleans, Louisiana, 70115
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Scott & White Medical Center
Temple, Texas, 76508
Boston Veterans Administration Healthcare System
West Roxbury, Massachusetts, 02132
About this study
Official title: A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.
- Conditions
- Ventral Hernia
- Being tested
- Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair)
- Keywords
- hernia repair, surgical mesh, co-morbidities
- 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 Reconstructive Tissue Matrix (Hernia Repair)Device
Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
Proceed Surgical Mesh (Hernia repair)Device
Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
| Study group | Role | What they receive |
|---|---|---|
| Strattice Reconstructive Tissue Matrix | Experimental | Use of Strattice Reconstructive Tissue Matrix to support hernia repair Receives: Device: Strattice Reconstructive Tissue Matrix (Hernia Repair) |
| Proceed Surgical Mesh | Active comparator | Use of Proceed Surgical Mesh to support hernia repair Receives: Device: Proceed Surgical Mesh (Hernia repair) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Events (SSEs)
Measured: Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Stopped early
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Martindale, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930787
- Sponsor's protocol ID
- LFC2007.03.01
- Acronym
- RAM2P
- Status last verified
- Sep 2013
- First submitted
- 29 Jun 2009
- Last updated
- 20 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
- ClinicalTrials.gov ID
- NCT00930787
- Acronym / sponsor ID
- RAM2P / LFC2007.03.01
- Conditions
- Ventral Hernia
- Keywords
- hernia repair, surgical mesh, co-morbidities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped early
- Enrolment
- 23 participants (actual)
- Lead sponsor
- LifeCellIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strattice Reconstructive Tissue Matrix | Experimental | Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)Use of Strattice Reconstructive Tissue Matrix to support hernia repair |
| Proceed Surgical Mesh | Active comparator | Device: Proceed Surgical Mesh (Hernia repair)Use of Proceed Surgical Mesh to support hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults of either gender
- must have 2 or more co-morbidities
Key exclusion criteria (3 listed)
- local or systemic infection
- expected survival of <24 months
- non-ambulatory
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 Reconstructive Tissue Matrix (Hernia Repair)Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline. | Device | Strattice Reconstructive Tissue Matrix |
| Proceed Surgical Mesh (Hernia repair)Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline. | Device | Proceed Surgical Mesh |
Primary outcome
Incidence of Surgical Site Events (SSEs)
Time frame: Postoperative Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ventral Hernia
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
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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.
Robert Martindale, MD principal investigator
Oregon Health and Science University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strattice Reconstructive Tissue Matrix (Hernia Repair) and Proceed Surgical Mesh (Hernia repair) in people with Ventral Hernia, run by LifeCell at 13 sites 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 2 inclusion and 3 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 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). 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?
Incidence of Surgical Site Events (SSEs) (time frame: Postoperative Day 30). 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 20 Nov 2013.