Strattice RICH Study
This information is intended only for residents of Ireland. The product information provided in this site is intended only for residents of Ireland. The products discussed herein may have different product labeling in different countries.
Announcing 12 Month Results from The Strattice™ RICH Study (Repair of Infected and Contaminated Hernias)
The Strattice™ RICH Study is the only published prospective, multicenter study of the repair of infected and contaminated hernias and the largest prospective study of a biological mesh in open hernia repair.
LifeCell is proud to announce the first Published Prospective, Multi-center Study of Repair of Infected or Contaminated Incisional Hernias (RICH) using Strattice™ Reconstructive Tissue Matrix. The 12 month data from this ongoing study was recently presented at the American College of Surgeons Meeting1 and a subset focused on component separation was also presented at the European Hernia Society Congress.2
This multicentre study included 80 complex and challenging patients, all of whom had clean contaminated, contaminated or dirty abdominal wall defects. This is a challenging patient population where:
- More than 60% had already had 1 or more prior repairs
- 33% had a history of abdominal wound infections
- 20% had infected mesh removed at the time of the repair with Strattice™
- 8% had fistulas present at the time of the repair with Strattice™
- Mean ±SD hernia defect area was 236±158cm2
Key insights and 12 months interim conclusions from this study were:
- Despite the complexity of the repairs in the setting of contamination and infection , no Strattice™ Tissue Matrix explants were required1,2
- Strattice™ Tissue Matrix reinforcement of component separation is an effective way for the repair of challenging hernia defects without presenting an additional safety risk2
- Strattice™ Tissue Matrix has been shown to provide definitive single-stage repair in the face of contamination or infection in more than 80% of subjects1,2
For more information please download the study results (PDF, 584 KB)
Contact your local business manager to learn more about the Strattice™ RICH study.
1. Itani K., et al, Prospective Multicenter Clinical Study of Single-Stage Repair of Infected or Contaminated Abdominal Incisional Hernias Using Strattice™ Reconstructive Tissue Matrix, abstract presented at the American College of Surgeons Meeting, Washington D.C. October 5th, 2010
2. Itani K., et al, Single stage repair of large contaminated hernia defects with Strattice™ Reconstructive Tissue Matrix reinforcement of component separation, Hernia 2010; 14(S1):S32-3.
Before use, physicians should review all risk information and essential prescribing information which can be found in the Strattice™ Reconstructive Tissue Matrix Instructions for Use (PDF, 4 MB)