Ventral Hernia
Conditions
Keywords
hernia repair, surgical mesh, co-morbidities
Brief summary
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.
Interventions
DEVICEStrattice Reconstructive Tissue Matrix (Hernia Repair)
Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
DEVICEProceed Surgical Mesh (Hernia repair)
Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline.
Sponsors
LifeCell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults of either gender * must have 2 or more co-morbidities
Exclusion criteria
* local or systemic infection * expected survival of \<24 months * non-ambulatory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Surgical Site Events (SSEs) | Postoperative Day 30 |
Countries
United States
Participant flow
Recruitment details
23 subjects recruited from 9 US sites between August 2009 and May 2010.
Participants by arm
| Arm | Count |
|---|---|
| Strattice Reconstructive Tissue Matrix Use of Strattice Reconstructive Tissue Matrix to support hernia repair | 14 |
| Proceed Surgical Mesh Use of Proceed Surgical Mesh to support hernia repair | 9 |
| Total | 23 |
Baseline characteristics
| Characteristic | Strattice Reconstructive Tissue Matrix | Proceed Surgical Mesh | Total |
|---|---|---|---|
| Age Continuous | 58.2 years STANDARD_DEVIATION 11.47 | 52.7 years STANDARD_DEVIATION 13.54 | 56 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 14 | 9 / 9 |
| serious Total, serious adverse events | 0 / 14 | 1 / 9 |
Outcome results
Primary
Incidence of Surgical Site Events (SSEs)
Time frame: Postoperative Day 30
Population: Study was terminated early and no analyses were conducted.