INFLUENCE OF EARLY (5 DAY) CORTICOSTEROID CESSATION ON WOUND COMPLICATIONS ASSOCIATED WITH SIROLIMUS: 1 YEAR RESULTS FROM A MULTICENTER TRIAL

Abstract

P304 Aims: Sirolimus and corticosteroids have been associated with an increased risk of wound healing complications. The promise of new available immunosuppressive drugs have inspired protocols that eliminate corticosteroids in the early posttransplant period. The purpose of this study was to evaluate the influence of early (5 day) corticosteroid cessation (ECSC) on wound healing complications associated with sirolimus (SRL) therapy in kidney transplant recipients. Methods: The study was a single limb, open label, multicenter (8 sites) pilot study. Inclusion criteria included: 1) age>18 yr, 2) primary transplant recipient. Exclusion criteria included: 1) African Americans, 2) current PRA>50%, 3) multiple organ transplant, 4) WBC<3000/ul, 5) fasting hypercholesterolemia or hypertriglyceridemia. Immunosuppression included: 1) Simulect 20 mg post transplant day (PTD) 0, 4, 2) tacrolimus 0.05 mg/kg/d target level 6-9 ng/ml PTD 1-30, then 4-8 ng/ml, 3) sirolimus 15 mg PTD 1; 10 mg PTD 2,3; 6 mg PTD 4 then adjust to level 8-15 ng/ml, 4) Solumedrol PTD 0-4 250, 250, 125, 65, 30 mg, DC. Results: 77 pts were enrolled. Data was available on wound complications in 77 pts. The following table presents the incidence of wound complications and demographic features of those pts.FigureConclusions: ECSC (5 day) under simulect, tacrolimus, and sirolimus results in: 1) a lower incidence of lymphocele formation (7.8%) than is reported in SRL/CS based immunosuppression regimens (8-20%), 2) a low incidence of wound abscesses. ECSC appears to offer a promising approach for avoiding wound complications associated with SRL therapy.