A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01205399
First received: September 17, 2010
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.


Condition
Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft [ Time Frame: 9 + Months ] [ Designated as safety issue: No ]
    A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.


Secondary Outcome Measures:
  • Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. [ Time Frame: 9+ Months ] [ Designated as safety issue: Yes ]
    Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit.

  • Procedural Time for AlloMax Surgical Graft Placement. [ Time Frame: 0 Days ] [ Designated as safety issue: No ]
    Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).


Enrollment: 78
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
AlloMax Surgical Graft Group

Detailed Description:

Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

Criteria

Inclusion Criteria:

  • Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
  • Have signed an informed consent form (ICF).

Exclusion Criteria:

  • Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
  • June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205399

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
United States, Missouri
Benrus Surgical Associates, Inc
Saint Peters, Missouri, United States, 63376
United States, New York
Winthrop Surgical Associates, Inc.
Mineola, New York, United States, 11501
United States, Oklahoma
Surgical Associates, Inc.
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Golla Center for Plastic Surgery
Pittsburg, Pennsylvania, United States, 15238
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: John S Roth, MD University of Kentucky
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01205399     History of Changes
Other Study ID Numbers: DVL-HE006
Study First Received: September 17, 2010
Results First Received: July 5, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 16, 2014