Hernia Repair in Multiply Morbid Patients (RAMP)
This study has been terminated.
Sponsor:
LifeCell
Information provided by:
LifeCell
ClinicalTrials.gov Identifier:
NCT00930787
First received: June 29, 2009
Last updated: April 4, 2011
Last verified: April 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventral Hernia |
Device: Strattice Reconstructive Tissue Matrix (Hernia Repair) Device: Proceed Surgical Mesh (Hernia repair) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed |
Resource links provided by NLM:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
Further study details as provided by LifeCell:
Primary Outcome Measures:
- Incidence of postoperative wound events [ Time Frame: Postoperative Day 30 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Resumption of Activities of Daily Living [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Concomitant medication usage [ Time Frame: Postoperative Day 30 ] [ Designated as safety issue: Yes ]
- Resource utilization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Hernia recurrence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Strattice Reconstructive Tissue Matrix
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
|
Device: 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.
|
|
Active Comparator: Proceed Surgical Mesh
Use of Proceed Surgical Mesh to support hernia repair
|
Device: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults of either gender
- must have 2 or more co-morbidities
Exclusion Criteria:
- local or systemic infection
- expected survival of <24 months
- non-ambulatory
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930787
Locations
| United States, Louisiana | |
| Tulane University | |
| New Orleans, Louisiana, United States, 70115 | |
| Louisiana Status University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston Veterans Administration Healthcare System | |
| West Roxbury, Massachusetts, United States, 02132 | |
| United States, Michigan | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Truman Medical Center | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New York | |
| Long Island Jewish - North Shore | |
| Lake Success, New York, United States, 11042 | |
| United States, Ohio | |
| University Hospital - Case Western | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 70115 | |
| Scott & White Medical Center | |
| Temple, Texas, United States, 76508 | |
Sponsors and Collaborators
LifeCell
Investigators
| Principal Investigator: | Robert Martindale, MD | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Randi Rutan, LifeCell Corporation |
| ClinicalTrials.gov Identifier: | NCT00930787 History of Changes |
| Other Study ID Numbers: | LFC2007.03.01 |
| Study First Received: | June 29, 2009 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by LifeCell:
|
hernia repair, surgical mesh, co-morbidities |
Additional relevant MeSH terms:
|
Hernia Hernia, Ventral Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 19, 2013