Regenerative effects of erythropoietin in burn and scald injuries

Not Applicable

Completed

• Conditions: Thermal injuries; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN95777824
• Lead Sponsor: Munich Technical University (Technische Universitaet Munchen) (Germany)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782555 2018 results in https://pubmed.ncbi.nlm.nih.gov/30429786/ (added 18/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-18
• Study Completion: 2013-09-30
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current outcomes as of 22/01/2009:<br> Time until complete re-epithelialisation of SGDS at a definite location on the lateral upper thigh.<br><br> Initial information at time of registration:<br> Time until complete re-epidermalisation of split skin donor sites at the right medial upper thigh.<br>