on-interventional long-term follow-up observation after treatment of skin defect with Geistlich Wound Matrix or autologous skin graft in the randomized controlled multi center study 300241-001
Completed
- Conditions
- surgical skin defect
- Registration Number
- DRKS00014991
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
Written informed consent,
Successful treatment of the skin defect with Geistlich Wound Matrix or autologous skin graft,
Final assessment (Visit 6) completed in the previous randomized controlled multi center clinical investigation 300241-001
Exclusion Criteria
Newly diagnosed diseases/conditions affecting skin appearance in the target area(s),
Relevant traum to the target site(s),
Surgical or radiotherapy treatment of the target area(s),
Participation in another study interfering with objective of this non-interventional long-term follow-up observation
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the scar by POSAS score (Patient and Observer Scar Assessment Scale) at 1/2 and 1 1/2 years after final visit of the main study 300241-001. The assessment comprises various parameters of functionality and appearance of the scar and is captured by means of validated questionnaire. The endpoint is derived from the assessment of the scar by the patient (50%) and by the two physicians (50%).
- Secondary Outcome Measures
Name Time Method Patients will be asked at all visits to give statement regarding the overall satisfaction of the treatment respectively of the clinical outcome (not satisfied, moderately satisfied, satisfied and fully satisfied).