Skin and Connective Tissue Diseases
Conditions
Keywords
wound healing, Bovine Lung Surfactant, SATOSU
Brief summary
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.
Interventions
DRUGSurfactants
DRUGSaline Solution
Sponsors
European Research Council
Prof. Dr. Dr. Ursula Mirastschijski
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Two healthy forearms, * No known chronical skin diseases, * Dermatoses or allergies, * Signed form of consent, * Caucasian
Exclusion criteria
* Pregnancy or nursing period, * Diabetes (Type I or II), * Systemic or infectious diseases, * Skin disease, * Known allergies against bovine products or wound dressings, * Mental diseases, missing ability to consent, * Addictive disorders (e.g. alcohol, drugs), * Peripheral circulatory disorder, Morbus Raynaud, * Current (or \< 4 weeks ago) participation in clinical trials
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure | day 2 |
Other
| Measure | 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 |
Countries
Germany
Outcome results
None listed