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

NCT01205399 | Completed Results

• 1 other identifier: DVL-HE006
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft

  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.

  9 + Months

Secondary Outcomes (2)

• Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.

  9+ Months

• Procedural Time for AlloMax Surgical Graft Placement.

  0 Days

Study Arms (1)

AlloMax Surgical Graft Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Have signed an informed consent form (ICF).

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (5)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Benrus Surgical Associates, Inc

City of Saint Peters, Missouri, 63376, United States

Location

Winthrop Surgical Associates, Inc.

Mineola, New York, 11501, United States

Location

Surgical Associates, Inc.

Tulsa, Oklahoma, 74136, United States

Location

Golla Center for Plastic Surgery

Pittsburgh, Pennsylvania, 15238, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single arm, observational study design.

Results Point of Contact

• Title: Dawn Heimer/Director, Clinical Affairs
• Organization: C. R. Bard: Davol, Inc.

dawn.heimer@crbard.com

401-825-8681

Study Officials

• John S Roth, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 18, 2017
• Results First Posted: August 23, 2012

Record last verified: 2017-01

Locations

US (5)