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/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.
Subject(s)
Burns/drug therapy , Erythropoietin/therapeutic use , Regeneration/drug effects , Research Design , Skin/drug effects , Adolescent , Adult , Aged , Burns/pathology , Burns/surgery , Clinical Protocols , Double-Blind Method , Drug Administration Schedule , Erythropoietin/administration & dosage , Female , Germany , Humans , Male , Middle Aged , Prospective Studies , Re-Epithelialization/drug effects , Recombinant Proteins/administration & dosage , Recombinant Proteins/therapeutic use , Severity of Illness Index , Skin/injuries , Skin/pathology , Skin Transplantation , Time Factors , Treatment Outcome , Young AdultABSTRACT
This article presents a retrospective analysis of a series of nine patients requiring reconstruction of exposed bone, tendons or joint capsules as a result of acute high-voltage injuries in a single burn centre. As an alternative to free tissue transfer, the dermal substitute Matriderm(®) was used in a one-stage procedure in combination with split-thickness skin grafts (STSG) for reconstruction. Nine patients, in the period between 2005 and 2009 with extensive high-voltage injuries to one or more extremities which required coverage of exposed functional structures as bone, tendons or joint capsule, were included. A total of 11 skin graftings and 2 local flaps were performed. Data including regrafting rate, complications, hospital stays, length of rehabilitation and time until return to work were collected. Eleven STSG in combination with Matriderm(®) were performed on nine patients (success rate 89%). One patient died. One patient needed a free-flap coverage as a secondary procedure. The median follow-up was 30 months (range 6-48 months). The clinical results of these nine treated patients concerning skin-quality and coverage of exposed tendons or joint capsule were very good. In high-voltage injuries free-flap failure occurs between 10% and 30% if performed within the first 4-6 weeks after trauma. The use of single-stage Matriderm(®) and skin grafting for immediate coverage described in this article is a reliable alternative to selected cases within this period.
