 
The GRAFTJACKET® Matrix has been studied in the treatment of deep, chronic diabetic foot ulcers to determine the product’s ability to support the body in the repair of these ulcers.
The following body of evidence suggests that the GRAFTJACKET® Matrix is a viable treatment alternative to deep diabetic foot ulcers. These results demonstrate that by using the GRAFTJACKET® Matrix in addition to good wound care and off-loading, the body can heal challenging chronic diabetic foot ulcers, and the rate of repair is faster than standard wound care alone. The first study divided the patients into two groups. Each group received similar treatment, including sharp debridement, weekly dressing changes and standard off-loading of the ulcer. The patients in the test group additionally had one application of the GRAFTJACKET® Matrix after debridement and before the first dressing was applied. Patients were followed weekly to determine the rate of healing at 4 weeks and complete healing at 12 weeks. STUDY 1 Reyzelman A, Crews RT, Moore JC, Moore L, Mukker JS, Offutt S, Tallis A, Turner WB, Vayser D, Winters C, Armstrong DG. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. International Wound Journal April 2009 (Epub ahead of print).
GRAFTJACKET® Matrix Doubles the Chance of HealingA Single Application of GRAFTJACKET® Matrix Provides:
Complete healing rate and mean healing time were 69.6% and 5.7 weeks, respectively, for the study group and 46.2% and 6.8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant (p = 0.029), with probability of healing in the study group 2.7 times higher than the control group. Kaplan-Meier Survivorship analysis for time to complete healing at 12 weeks revealed a significantly higher non-healing rate (p=0.015) for the control group (53.9%) compared to the study group (30.4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate (p=0.019), a statistically significant difference in nonhealing rate between groups was calculated (p=0.023), with probabilty of healing 2.0 times higher in the study versus control group. This study supports the use of a single-application of GRAFTJACKET® Matrix therapy as an effective treatment of diabetic, neuropathic ulcers. Study 2 A Multi-Center Study Involving the Use of a Human Acellular Dermal Regenerative Tissue Matrix
for the Treatment of Diabetic Lower Extremity Wounds
Study 3 Brigido SA, Boc SF, Lopez RC. Effective Management of Major Lower Extremity Wounds Using an Acellular Regenerative Tissue Matrix: A Pilot Study. Orthopedics 2004; 27(1S): s145-s149.
A third study also compares a single application of GRAFTJACKET® Matrix to sharp debridement, weekly dressing changes, and standard offloading alone. All patients were seen weekly. By week 16, 12 of 14 patients treated with GRAFTJACKET® Matrix demonstrated complete wound closure compared with 4 of 14 patients in the control group. Study 4 Brigido, SA. The Use of an Acellular Dermal Regenerative Tissue Matrix in the Treatment of Lower Extremity Wounds: A prospective 16-week Pilot Study. Accepted to International Wound Journal, 2006.
A fourth study included a series of 17 consecutive patients with deep ulcers. These patients were treated with sharp debridement, a single application of GRAFTJACKET® Matrix, and standard off-loading. These patients were followed for 20 weeks to determine complete healing and the average time to complete healing. Study 5 Martin BR, Sangalang M, Wu SC, Armstrong DG. Outcomes of allogenic matrix therapy in treatment of diabetic foot wounds. International Wound Journal 2005; 2(2): 161-165.
A fifth study is a small series of 11 patients with Wagner Grade I & II diabetic foot ulcers. These patients were treated with sharp debridement, a single application of GRAFTJACKET® Matrix, and standard off-loading. These patients were followed for 12 weeks to determine efficacy and healing time. Study 6 Yeager DA, Oliverio J. Investigation of GRAFTJACKET® Regenerative Tissue Matrix For Ulcer Repair on Full-Thickness Lower Extremity Ulcers. Accepted as an ACFAS 2006 Scientific Poster Exhibit.
A sixth study is a retrospective review of 15 consecutive complex wounds. Comorbidities included peripheral vascular disease, diabetes, infection, osteomyelitis, and neuropathy. Treatment included sharp debridement, infection control (if applicable, including local and systemic antibiotics), a single application of GRAFTJACKET® Matrix, and standard off-loading. The patients were followed for 12 weeks. Study 7 Liden BA, Hartman JF, Wright ML. The Use of an Acellular Regenerative Tissue Matrix for the Management of Complex Lower Extremity Wounds. Accepted as an ACFAS 2006 Scientific Poster Exhibit.
*Completely healed is defined as closure of the wound with no drainage. For further reimbursement questions, please contact your local sales representative, or submit additional questions to Code It Wright.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Copyright ©2010 Wright Medical Technology, Inc. All rights reserved. Please see Site Disclaimers for complete information regarding contents, correspondence, surgical procedures, product information, and links to other web sites. |