N/A
N=78
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01205399 ↗Enrolled (actual)
78
Serious AEs
64.1%
Results posted
Aug 2012
Primary outcome: Primary: Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft — 17 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft |
17 | — |
| SECONDARY Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. |
166 | — |
| SECONDARY Procedural Time for AlloMax Surgical Graft Placement. |
161.8 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01205399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.