Wound-healing complications after kidney transplantation: a prospective, randomized comparison of sirolimus and tacrolimus

Transplantation. 2004 May 27;77(10):1555-61. doi: 10.1097/01.tp.0000123082.31092.53.


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 sirolimus level, the wound complication rate in the sirolimus group was 35% (9 of 26 patients; P = 0.1040).

Conclusions: The use of sirolimus-based immunosuppressive regimens leads to a higher incidence of wound-healing complications and will require new approaches to patient selection and management to decrease their incidence.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Aged, 80 and over
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Graft Rejection / epidemiology
  • Graft Survival
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects*
  • Incidence
  • Kidney / physiopathology
  • Kidney Transplantation*
  • Male
  • Middle Aged
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / analogs & derivatives*
  • Sirolimus / administration & dosage
  • Sirolimus / adverse effects*
  • Survival Analysis
  • Tacrolimus / administration & dosage
  • Tacrolimus / adverse effects*
  • Wound Healing / drug effects*


  • Immunosuppressive Agents
  • Mycophenolic Acid
  • Sirolimus
  • Tacrolimus