Reepidermalization of Split Skin Donor Sites at the lateral upper thigh
Conditions
Interventions
Trade Name: NeoRecormon
Product Name: NeoRecormon
Pharmaceutical Form: Injection
INN or Proposed INN: EPOETIN BETA
CAS Number: 122312543
Concentration unit: IU international unit(s)
Concentration type
Sponsors
Faculty of Medicine, Technische Universitaet Muenchen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting - Men and women, age > 18 and = 75 years - Secure Contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Admission later than 24 hours after injury - Informed consent missing - Hematological disorders (anaemia, lymphoma, leukemia, inborn coagulation diseases) - Pregnancy or breast-feeding - Estimated survival shorter than one week (abbreviated burn severity index (ABSI) > 12) in patients older than 40 years of age - 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 - Body weight 110 kg - Upper lateral thights of legs thermally injured - Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the protocol. - Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study. - Treatment with any investigational product in the last 12 months before study entry - Treatment with any immunosuppressive therapy, cancer-related chemotherapy or radiation therapy in the past 12 months - History of hypersensitivity to the investigational products - Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2) - Clinically relevant cardiovascular (s.p. cardiac infarction, coronary heart disease (CHD), thrombembolic disease, thrombembolic events shortly before admission), hepatic (Child B or C liver disease). endocrine (morbid obesity (BMI > 40)) or systemic (cancer) disease (malignoma) - Epileptiform diseases - Phenylketonuria - HIV disease, AIDS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time until complete reepithelialization of skin graft donor sites (thickness 0.3 mm) at a definite location on the lateral upper thigh;Secondary Objective: Time until complete wound healing of type 2a SDW Time until complete wound healing of skin graft Cellular and molecular regenerative effects in SGDS and type 2a SDW, Endothelial Progenitor Cell (EPC) recruitment, [EPO] receptor upregulation, protein expression) Quality of scar formation in conservatively and operatively treated wound locations Number of packed red cells units, which are transfused during the treatment interval Laboratory parameters (differential blood cell count, iron storage, [EPO]/serum) Cardiopulmonary and renal parameters Quality of life 12 months after trauma Adverse events Gender differences in monitored data ;Primary end point(s): Time until complete reepithelialization of skin graft donor sites (thickness 0.3 mm) at a definite location on the lateral upper thigh | — |
Countries
Germany
Outcome results
None listed