E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reepidermalization of Split Skin Donor Sites at the lateral upper thigh |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Time until complete reepithelialization of skin graft donor sites (thickness 0.3 mm) at a definite location on the lateral upper thigh |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 < 50 kg or > 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |