Thermal injuries Injury, Occupational Diseases, Poisoning Thermal injuries
Conditions
Interventions
Current interventions as of 22/01/2009:
Erythropoietin 150 IU/kg body weight/application every second day. Subcutaneous drug administration every other day will be performed over 3 wee
Sponsors
Munich Technical University (Technische Universitaet Munchen) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current criteria as of 22/01/2009: 1. 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting 2. Men and women, aged greater than 18 and less than or equal to 75 years 3. Secure contraception Initial information at time of registration: 1. Deep 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting 2. Aged greater than or equal to 18 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/04/2013: 1. Admission later than 24 hours after injury 2. Haematological disorders (anaemia, lymphoma, leukaemia, inborn coagulation diseases) 3. Pregnancy or breast-feeding 4. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] greater than 12) in patient older than 40 years of age 5. Total burn surface area involved less than 60% in patients older than 40 years of age, in patients younger than 40 years of age no limitation of maximum burned body surface and no limitation of ABSI score will be considered 6. Body weight less than 50 kg or greater than 110 kg 7. Upper lateral thights of leg thermally injured 8. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the protocol 9. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 10. Treatment with any investigational product in the last 12 months before study entry 11. Treatment with any immunosuppressive therapy, cancer-related chemotherapy or radiation therapy in the past 12 months 12. History of hypersensitivity to the investigational products 13. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol 14. Clinically relevant cardiovascular (s.p. cardiac infarction, coronary heart disease [CHD], thromboembolic disease, thromboembolic events shortly before admission), hepatic (Child B or C liver disease), endocrine (morbid obesity: body mass index [BMI] greater than 40) or systemic (cancer) disease (malignoma) 15. Epileptiform diseases 16. Phenylketonuria 17. Human immunodeficiency virus (HIV) disease, acquired immune-deficiency virus (AIDS) 18. Informed consent missing Previous exclusion criteria as of 22/01/2009: Subjects presenting with any of the following will not be included in the study: 1. Admission later than 24 hours after injury 2. Informed consent given later than 48 hours after trauma 3. Suicide attempt 4. Skin Graft Donor Site (SGDS) created later than 4 days after trauma 5. Begin of treatment with study drug less than 24 hours before creation of SGDS 6. Haematological disorders (anaemia, lymphoma, leukaemia, inborn coagulation diseases) 7. Pregnancy or breast-feeding 8. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] greater than 12) 9. Total burn surface area involved less than 10% or greater than 50% 10. Body weight less than 50 kg or greater than 110 kg 11. Upper lateral thigh of leg thermally injured 12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 13. Subject unlikely to comply with protocol, e.g., uncooperative attitud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current outcomes as of 22/01/2009: Time until complete re-epithelialisation of SGDS at a definite location on the lateral upper thigh. Initial information at time of registration: Time until complete re-epidermalisation of split skin donor sites at the right medial upper thigh. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current outcomes as of 22/01/2009: 1. Time until complete wound healing of type 2a SDW 2. Time until complete wound healing of skin graft 3. Cellular and molecular regenerative effects in SGDS and type 2a SDW, endothelial progenitor cell (EPC) recruitment, EPO receptor upregulation, protein expression 4. Quality of scar formation in conservatively and operatively treated wound locations 5. Number of packed red cells units, which are transfused during the treatment interval 6. Laboratory parameters (differential blood cell count, iron storage, EPO) 7. Cardiopulmonary parameters 8. Quality of life 12 months after trauma 9. Mortality (within 21 days, hospital stay and 1 year) 10. Adverse events 11. Gender differences in monitored data Initial information at time of registration: 1. Number of packed red cells units, which are transfused during the treatment interval 2. Laboratory parameters (differential blood cell count, iron storage, erythropoietin [EPO]) 3. Cardiopulmonary and renal parameters 4. Time until complete wound healing of deep 2° thermal wounds is achieved 5. Scar formation in conservatively and operatively treated wound locations 6. Quality of life 12 months after hospital discharge 7. Mortality (within 28 days, hospital stay and 1 year) 8. Adverse effects | — |
Countries
Germany
Outcome results
None listed