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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000890-11 | EudraCT Number | ||
| DRKS00011353 | Other Identifier | German Clinical Trials Register (DRKS) |
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| Name | Class |
|---|---|
| European Research Council | OTHER |
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Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in preterm infants. Here the drug is administered via airways.
The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is not yet approved for the treatment of wound healing disorders. In the planned clinical trial Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No substance related side effects were observed during the application via airways in neonates.
The innovative idea to use lung surfactant for skin wound healing derived from two observations. First, when the skin is injured, the barrier protecting the moist body surface from the dry environment is discontinued and in part lost.
Lung surfactant has several characteristics that might be beneficial for treatment of chronic cutaneous wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant | Experimental | Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times |
|
| Saline | Active Comparator | 0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfactants | Drug |
| ||
| Saline Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits | days 2,4,6,8,10,12,14 post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface | up to 14 days and one time follow up after 30 days | |
| Pain measured by mean Visual Analogue Scale over all visits | days 2,4,6,8,10,12,14 post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | up to 14 days and one time follow up after 30 days | |
| Number of Participants With Abnormal Laboratory Values | Baseline and day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ursula Mirastschijski, Prof. Dr. | University of Bremen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bremen | Bremen | 28359 | Germany |
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| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013501 | Surface-Active Agents |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 2 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 4 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 6 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 8 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 10 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 12 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 14 |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |