Hernia Repair in Multiply Morbid Patients (RAM2P)

This study has been terminated.
(Stopped early)
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00930787
First received: June 29, 2009
Last updated: September 17, 2013
Last verified: September 2013

June 29, 2009
September 17, 2013
August 2009
May 2010   (final data collection date for primary outcome measure)
Incidence of Surgical Site Events (SSEs) [ Time Frame: Postoperative Day 30 ] [ Designated as safety issue: Yes ]
Incidence of postoperative wound events [ Time Frame: Postoperative Day 30 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00930787 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
Hernia Repair in Multiply Morbid Patients
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Ventral Hernia
  • 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.
  • 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.
  • Experimental: Strattice Reconstructive Tissue Matrix
    Use of Strattice Reconstructive Tissue Matrix to support hernia repair
    Intervention: Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)
  • Active Comparator: Proceed Surgical Mesh
    Use of Proceed Surgical Mesh to support hernia repair
    Intervention: Device: Proceed Surgical Mesh (Hernia repair)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00930787
LFC2007.03.01
Yes
LifeCell
LifeCell
Not Provided
Principal Investigator: Robert Martindale, MD Oregon Health and Science University
LifeCell
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP