Hernia Repair in Multiply Morbid Patients (RAM2P)

LifeCell

Status and phase: Terminated; Phase 4

Conditions: Ventral Hernia

Treatments: Device: Proceed Surgical Mesh (Hernia repair); Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930787

LFC2007.03.01

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Strattice Reconstructive Tissue Matrix

Experimental group

Description:

Use of Strattice Reconstructive Tissue Matrix to support hernia repair

Treatment:

Device: Strattice Reconstructive Tissue Matrix (Hernia Repair)

Proceed Surgical Mesh

Active Comparator group

Description:

Use of Proceed Surgical Mesh to support hernia repair

Treatment:

Device: Proceed Surgical Mesh (Hernia repair)