TY - JOUR
T1 - A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: Study protocol for a randomized controlled trial
AU - Günter, Christina I.
AU - Bader, Augustinus
AU - Dornseifer, Ulf
AU - Egert, Silvia
AU - Dunda, Sebastian
AU - Grieb, Gerrit
AU - Wolter, Thomas
AU - Pallua, Norbert
AU - von Wild, Tobias
AU - Siemers, Frank
AU - Mailänder, Peter
AU - Thamm, Oliver
AU - Ernert, Carsten
AU - Steen, Michael
AU - Sievers, Reiner
AU - Reichert, Bert
AU - Rahmanian-Schwarz, Afshin
AU - Schaller, Hans
AU - Hartmann, Bernd
AU - Otte, Max
AU - Kehl, Victoria
AU - Ohmann, Christian
AU - Jelkmann, Wolfgang
AU - Machens, Hans Günther
PY - 2013/5/3
Y1 - 2013/5/3
N2 - 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.Via the inhibition of inflammatory reactions and of apoptosis, stem cell recruitment, advancement of angiogenesis and growth factor release, EPO enhances healing and thus restitutio ad integrum after trauma. Human skin contains EPO receptors and is able to synthesize EPO. We therefore hypothesize that EPO is able to optimize wound healing in thermally injured patients.Methods/Design: 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.Discussion: 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.Trial registration: EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.
AB - 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.Via the inhibition of inflammatory reactions and of apoptosis, stem cell recruitment, advancement of angiogenesis and growth factor release, EPO enhances healing and thus restitutio ad integrum after trauma. Human skin contains EPO receptors and is able to synthesize EPO. We therefore hypothesize that EPO is able to optimize wound healing in thermally injured patients.Methods/Design: 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.Discussion: 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.Trial registration: EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.
UR - http://www.scopus.com/inward/record.url?scp=84877801025&partnerID=8YFLogxK
U2 - 10.1186/1468-6708-14-124
DO - 10.1186/1468-6708-14-124
M3 - Journal articles
C2 - 23782555
AN - SCOPUS:84877801025
VL - 14
JO - Trials
JF - Trials
IS - 1
M1 - 124
ER -
