NCT00930787

Hernia Repair in Multiply Morbid Patients

A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: LifeCell · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Strattice 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.
DEVICE	Proceed 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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-06-30
• Last updated: 2013-11-20
• Results posted: 2013-11-20

Locations

13 sites across 1 country: United States