Hernia
Conditions
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.
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.
Interventions
None listed
Sponsors
C. R. Bard
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft | 9 + Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. | 9+ Months | 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. | 0 Days | 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). |
Countries
United States
Participant flow
Recruitment details
From September 2010 through October 2011 a total of 78 subjects were enrolled at 4 study centers in the United States. The fifth site was terminated because subject data could not be source verified.
Participants by arm
| Arm | Count |
|---|---|
| AlloMax Surgical Graft Group | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | AlloMax Surgical Graft Group |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 11.07 |
| Body Mass Index | 36.7 kilograms per square meter STANDARD_DEVIATION 9.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gender Female | 43 Participants |
| Gender Male | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 74 Participants |
| Region of Enrollment United States | 78 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 78 |
| serious Total, serious adverse events | 50 / 78 |
Outcome results
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.
Time frame: 9 + Months
Population: All enrolled subjects that could be verified through historical medical record review.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AlloMax Surgical Graft Group | Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft | 17 participants |
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.
Time frame: 9+ Months
Population: All enrolled subjects that could be verified through historical medical record review.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AlloMax Surgical Graft Group | Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. | 166 complication events |
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).
Time frame: 0 Days
Population: All enrolled subjects that could be verified through historical medical record review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AlloMax Surgical Graft Group | Procedural Time for AlloMax Surgical Graft Placement. | 161.8 minutes | Standard Deviation 58.45 |