Wound-healing complication after kidney transplantation

A prospective, randomized comparison of sirolimus and tacrolimus

Patrich G. Dean, William J. Lund, Timothy S. Larson, Mikel Prieto, Scott L. Nyeberg, Michael B. Ishitani, Walter K Kremers, Mark D Stegall

Research output: Contribution to journalArticle

235 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1555-1561
Number of pages7
JournalTransplantation
Volume77
Issue number10
DOIs
StatePublished - May 27 2004

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Tacrolimus
Sirolimus
Kidney Transplantation
Wound Healing
Mycophenolic Acid
Body Mass Index
Prednisone
Incidence
Wounds and Injuries
Logistic Models
Antilymphocyte Serum
Wound Infection
Patient Selection
Allografts
Regression Analysis
Kidney

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Wound-healing complication after kidney transplantation : A prospective, randomized comparison of sirolimus and tacrolimus. / Dean, Patrich G.; Lund, William J.; Larson, Timothy S.; Prieto, Mikel; Nyeberg, Scott L.; Ishitani, Michael B.; Kremers, Walter K; Stegall, Mark D.

In: Transplantation, Vol. 77, No. 10, 27.05.2004, p. 1555-1561.

Research output: Contribution to journalArticle

Dean, Patrich G. ; Lund, William J. ; Larson, Timothy S. ; Prieto, Mikel ; Nyeberg, Scott L. ; Ishitani, Michael B. ; Kremers, Walter K ; Stegall, Mark D. / Wound-healing complication after kidney transplantation : A prospective, randomized comparison of sirolimus and tacrolimus. In: Transplantation. 2004 ; Vol. 77, No. 10. pp. 1555-1561.
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title = "Wound-healing complication after kidney transplantation: A prospective, randomized comparison of sirolimus and tacrolimus",
abstract = "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.",
author = "Dean, {Patrich G.} and Lund, {William J.} and Larson, {Timothy S.} and Mikel Prieto and Nyeberg, {Scott L.} and Ishitani, {Michael B.} and Kremers, {Walter K} and Stegall, {Mark D}",
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T1 - Wound-healing complication after kidney transplantation

T2 - A prospective, randomized comparison of sirolimus and tacrolimus

AU - Dean, Patrich G.

AU - Lund, William J.

AU - Larson, Timothy S.

AU - Prieto, Mikel

AU - Nyeberg, Scott L.

AU - Ishitani, Michael B.

AU - Kremers, Walter K

AU - Stegall, Mark D

PY - 2004/5/27

Y1 - 2004/5/27

N2 - 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.

AB - 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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