Background. Sirolimus has been associated with an increased risk of wound-healing complications in several retrospective analyses. The authors compared the rates of wound-healing complications in renal allograft recipients in a prospective, randomized trial of sirolimus-mycophenolate mofetil-prednisone versus tacrolimus-mycophenolate mofetil-prednisone. Methods. All patients received antithymocyte globulin induction. In the first phase of the study, patients (n=77) were included regardless of body mass index (BMI). In the second phase (n=46 patients), the authors excluded patients with a BMI greater than 32 kg/m2, and the target trough sirolimus level was lowered to 10 to 15 ng/mL (previously 15-20 ng/mL). Multivariate logistic regression analyses were performed to identify predictors of wound complications. Results. Fifty-nine patients received tacrolimus and 64 received sirolimus and were included in subsequent analyses. The incidence of complications was 8% (5 of 59) in the tacrolimus group and 47% (30 of 64) in the sirolimus group (P<0.0001). Rates of perigraft fluid collections, superficial wound infections, and incisional herniae were significantly higher in the sirolimus group. Multivariate logistic regression showed only sirolimus (P=0.0001) and BMI (P= 0.0021) to independently correlate with complications. In the first phase of the study, the wound complication rate in the sirolimus group was 55% (21 of 38 patients). After excluding obese recipients and decreasing the target sirolimims level, the wound complication rate in the sirolimus group was 35% (9 of 26 patients; P=0.1040). Conclusions. The use of sirolimus-based immuno-suppressive regimens leads to a higher incidence of wound-healing complications and wIll require new approaches to patient selection and management to decrease their incidence.
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