Open Access Study protocol

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial

Christina Irene Günter1*, Augustinus Bader2, Ulf Dornseifer3, Silvia Egert15, Sebastian Dunda4, Gerrit Grieb4, Thomas Wolter4, Norbert Pallua4, Tobias von Wild5, Frank Siemers5, Peter Mailänder5, Oliver Thamm6, Carsten Ernert7, Michael Steen7, Reiner Sievers8, Bert Reichert8, Afshin Rahmanian-Schwarz9, Hans Schaller9, Bernd Hartmann10, Max Otte11, Victoria Kehl12, Christian Ohmann13, Wolfgang Jelkmann14 and Hans-Günther Machens1

Author Affiliations

1 Coordinating Investigator: “EPO in Burns”, Clinic for Plastic Surgery and Hand Surgery, Klinikum Rechts der Isar, Technische Universität München, Ismaninger Str. 22, Munich, 81675, Germany

2 Institute for Cell Techniques and Applied Stem Cell Biology, University of Leipzig, Deutscher Platz 5, Leipzig, 04103, Germany

3 Klinik für Plastische, Rekonstruktive, Hand- und Verbrennungschirurgie, Klinikum Bogenhausen, Englschalkinger Str. 77, Munich, 81925, Germany

4 Department of Plastic Surgery, Hand Surgery, Burn Center, University Hospital of the RWTH Aachen University, Pauwelsstr. 30, Aachen, 52074, Germany

5 Sektion für Plastische Chirurgie und Handchirurgie, Zentrum für Schwerbrandverletzte, Universitätsklinikum Schleswig Holstein, Lübeck, 23538, Germany

6 Abteilung für Plastische, Rekonstruktive und Handchirurgie, Krankenhaus Merheim, Ostmerheimer Str. 200, Köln, 51109, Germany

7 Klinik für Plastische und Handchirurgie, Brandverletztenzentrum, BG-Kliniken Bergmannstrost Halle, Halle, 06112, Germany

8 Klinik für Plastische, Wiederherstellende und Handchirurgie, Zentrum für Schwerbrandverletzte, Klinikum Nürnberg-Süd, Breslauer Strasse 201, Nürnberg, 90471, Germany

9 Klinik für Hand-, Plastische, Rekonstruktive und Verbrennungschirurgie, Berufsgenossenschaftliche Unfallklinik, Tübingen, 72076, Germany

10 Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Unfallkrankenhaus Berlin, Berlin, 12683, Germany

11 Klinik für Hand-, Plastische und Rekonstruktive Chirurgie, Schwerbrand Verletztenzentrum, Berufsgenossenschaftliche Unfallklinik, Ludwigshafen, 67071, Germany

12 Institute of Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, Munich, 81675, Germany

13 Coordination Centre for Clinical Studies, Heinrich-Heine-University, Moorenstr. 5, Düsseldorf, 40225, Germany

14 Institute for Physiology, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23562, Germany

15 Müncher Studienzentrum, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, Munich, 81675, Germany

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Trials 2013, 14:124  doi:10.1186/1468-6708-14-124

Published: 3 May 2013

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.

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 webcite.

Keywords:
Erythropoietin (EPO); Burns; Regenerative medicine; Wound healing; Clinical trial, Randomization