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

Hernia Clinical Trial

— AlloMax  

Official title:

A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205399
• Other study ID #: DVL-HE006
• Status: Completed
• Phase: N/A
• First received: September 17, 2010
• Last updated: January 13, 2017
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2017
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Winthrop Surgical Associates, Inc.	Mineola	New York
United States	Golla Center for Plastic Surgery	Pittsburg	Pennsylvania
United States	Benrus Surgical Associates, Inc	Saint Peters	Missouri
United States	Surgical Associates, Inc.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.	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.	9+ Months
Secondary	Procedural Time for AlloMax Surgical Graft Placement.	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).	0 Days