Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
230
Trial Sponsor
Clinical Trial Start Date
2009
0Primary Completion Date
2010
0Study Completion Date
2010
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Interventional Trial Phase
Phase 40
Participating Facility
Official Name
A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed0
Last Updated
November 20, 2013
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Single0
Masked Party
Outcomes Assessor0
Other attributes
Intervention Treatment
Proceed Surgical Mesh (Hernia repair)0
Strattice Reconstructive Tissue Matrix (Hernia Repair)0
Study 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.
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