The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for XXXX .

@entity1 @entity7502 @entity260 @entity158 @entity547 @entity169 @entity1118
PURPOSE: Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin @entity158 . METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore @entity7502 mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 @entity1 . These @entity1 are being followed for a minimum of 2  years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a @entity169 as measured by resumption of activities of daily living. Secondary outcomes include @entity1118 , @entity260 and the incidence of re-herniation at 12 and 24  months. RESULTS: This paper discusses the study design, @entity1 recruitment and the current status of the clinical trial. The study involves nine medical centers, all with extensive experience in @entity547 repair. After 24  months of enrollment, 172 @entity1 were randomized and recruitment was then closed. All @entity1 underwent elective repair of primary unilateral @entity169 as an outpatient operation. Follow up data are being collected. Data analyses are scheduled at 3, 12, and 24  months postoperatively. CONCLUSION: We report the design of a multi-center, third-party blinded, randomized clinical trial comparing a new surgical device with existing technology in the repair of @entity169 . We believe this investigator-designed and conducted trial could serve as a model for similar trials examining surgical devices performed in collaboration with industry.
