摘要：Background: Although it was itally assumed that erythropoietin (EPO) was a hormone that only afectederythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute andchronic tissue damage.Via the inhibition of infammatory reactions and of apoptosis, stem cell recruitment, advancement of angiogenesisand growth factor release, EPO enhances healing and thus restitutio ad integrum after trauma. Human skin containsEPO receptors and is able to synthesize EPO. We therefore hypothesize that EPO is able to optimize wound healingin thermally injured patients.Methods/Design: This is a large, prospective, randomized, double. blind, multi- center study, funded by the GermanFederal Ministry of Education and Research, and fully approved by the designated ethics comitte. The trial,which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is beingcarried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medicationevery other day for 21 days (EPO 150 IU/kg body weight or placebo). A followup of one year is planned. Theprimary endpoint of this study is the time until complete re epithelialization of a defined skin graft donor site isreached. Furthermore, clinical parameters such as wound healing, sCar formation (using the Vancouver scar scale),laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to bedetermined. The results will be carefully evaluated for gender diferences.Discussion: We are seeking new insights into the mechanisms of wound healing in thermally injured patients andmore detailed information about the role EPO plays, speically in these complex interactions. We additionallyexpect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries.Trial registration: EudraCT Number: 2006-002886 38, Protocol Number: 0506, ISRCT Number: ht/:/co/trollede trials.com/ISRCTN95777824/ISRCTN95777824.
