Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: August 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ventral Hernia
Interventions: Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)
Device: Proceed Surgical Mesh (Hernia repair)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
23 subjects recruited from 9 US sites between August 2009 and May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Strattice Reconstructive Tissue Matrix Use of Strattice Reconstructive Tissue Matrix to support hernia repair
Proceed Surgical Mesh Use of Proceed Surgical Mesh to support hernia repair

Participant Flow:   Overall Study
    Strattice Reconstructive Tissue Matrix     Proceed Surgical Mesh  
STARTED     14     9  
COMPLETED     14     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Strattice Reconstructive Tissue Matrix Use of Strattice Reconstructive Tissue Matrix to support hernia repair
Proceed Surgical Mesh Use of Proceed Surgical Mesh to support hernia repair
Total Total of all reporting groups

Baseline Measures
    Strattice Reconstructive Tissue Matrix     Proceed Surgical Mesh     Total  
Number of Participants  
[units: participants]
  14     9     23  
Age  
[units: years]
Mean ± Standard Deviation
  58.2  ± 11.47     52.7  ± 13.54     56  ± 12  
Gender  
[units: participants]
     
Female     11     3     14  
Male     3     6     9  



  Outcome Measures

1.  Primary:   Incidence of Surgical Site Events (SSEs)   [ Time Frame: Postoperative Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Michael Franz
Organization: LifeCell
phone: 908094701100
e-mail: mfranz@lifecell.com


No publications provided


Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00930787     History of Changes
Other Study ID Numbers: LFC2007.03.01
Study First Received: June 29, 2009
Results First Received: August 16, 2012
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board