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Randomized Controlled Trial
. 2009 Jan-Feb;23(1):16-22.
doi: 10.1111/j.1399-0012.2008.00890.x. Epub 2008 Aug 22.

Steroid withdrawal five days after renal transplantation allows for the prevention of wound-healing complications associated with sirolimus therapy

Affiliations
Randomized Controlled Trial

Steroid withdrawal five days after renal transplantation allows for the prevention of wound-healing complications associated with sirolimus therapy

Silvio Sandrini et al. Clin Transplant. 2009 Jan-Feb.

Abstract

Background: Sirolimus (SRL) can increase the risk of wound complications. In this study, we investigated the impact of steroids when added to SRL, in this side effect.

Methods: One hundred and forty-eight patients entered prospective studies comparing early (fifth day) with late (sixth month) steroid withdrawal. All patients were on SRL, added either to Tacrolimus (n = 56) or to cyclosporine (n = 97). At 15th day after transplantation, 68 patients were on steroids (On-St group) and 80 were not (Off-St group). Wound complications considered were as follows: dehiscence, lymphocele, wound leakage, hematoma and seromas. Risk factors under analysis were as follows: body mass index, diabetes, rejection, creatininemia, length of dialysis before transplantation, recipient age, being on steroids at 15th day, SRL levels.

Results: The overall incidence of wound complications was significantly lower in Off-St group than in On-St group: 18.8% vs. 45.6%, respectively (p < 0.0004). In detail, lymphocele: 5.0% vs. 32.3% (p < 0.0001); dehiscence 0% vs. 10.3% (p < 0.009), leakage 6.2% vs. 8.8% (p = NS), seromas 1.4% vs. 7.5% (NS). At multivariate analysis, the addition of steroids to SRL increases 4.2-fold the risk for wound complications.

Conclusions: Early steroid withdrawal is effective in preventing both the incidence and the severity of wound-healing complications because of SRL regime, even when started with a loading dose.

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