title: A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage.
  
  
  METHODS
  This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. 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 be determined. The results will be carefully evaluated for gender differences.
  
  
  CONCLUSIONS
  We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries.
  
  
  BACKGROUND
  EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.
authors.forename: Christina Irene
authors.initials: CI
authors.lastname: Günter
authors.forename: Augustinus
authors.initials: A
authors.lastname: Bader
authors.forename: Ulf
authors.initials: U
authors.lastname: Dornseifer
authors.forename: Silvia
authors.initials: S
authors.lastname: Egert
authors.forename: Sebastian
authors.initials: S
authors.lastname: Dunda
authors.forename: Gerrit
authors.initials: G
authors.lastname: Grieb
authors.forename: Thomas
authors.initials: T
authors.lastname: Wolter
authors.forename: Norbert
authors.initials: N
authors.lastname: Pallua
authors.forename: Tobias
authors.initials: T
authors.lastname: von Wild
authors.forename: Frank
authors.initials: F
authors.lastname: Siemers
authors.forename: Peter
authors.initials: P
authors.lastname: Mailänder
authors.forename: Oliver
authors.initials: O
authors.lastname: Thamm
authors.forename: Carsten
authors.initials: C
authors.lastname: Ernert
authors.forename: Michael
authors.initials: M
authors.lastname: Steen
authors.forename: Reiner
authors.initials: R
authors.lastname: Sievers
authors.forename: Bert
authors.initials: B
authors.lastname: Reichert
authors.forename: Afshin
authors.initials: A
authors.lastname: Rahmanian-Schwarz
authors.forename: Hans
authors.initials: H
authors.lastname: Schaller
authors.forename: Bernd
authors.initials: B
authors.lastname: Hartmann
authors.forename: Max
authors.initials: M
authors.lastname: Otte
authors.forename: Victoria
authors.initials: V
authors.lastname: Kehl
authors.forename: Christian
authors.initials: C
authors.lastname: Ohmann
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Jelkmann
authors.forename: Hans-Günther
authors.initials: HG
authors.lastname: Machens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002056:Burns / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002985:Clinical Protocols; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D062326:Re-Epithelialization / Q000187:drug effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012038:Regeneration / Q000187:drug effects*; D012107:Research Design; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects* / Q000293:injuries / Q000473:pathology; D016038:Skin Transplantation; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin