Randomised controlled multicenter study to evaluate safety and performance of Geistlich Wound Matrix versus autologous skin graft in the treatment of skin defects
- Conditions
- surgical skin lesion
- Registration Number
- DRKS00010930
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
• Written informed consent
• Age 18 years or older
• Acute skin defect post surgical excision
• Maximal size of skin defect 20 x 30 mm
• Skin defect of at least 10 mm in diameter
• Indication for transplantation of autologous skin graft
• Healthy skin within 10 mm around the excision margin
• Estimated life expectancy of > 1 year
• General contraindications for surgical treatments
• Severe diseases (e.g. active carcinoma) upon decision of the investigator
• Intention to perform flap surgery
• Indication for secondary wound healing
• Indication for primary wound closure (i.e. amount and quality of adjacent soft tissue sufficient to allow for appropriate wound closure by suturing)
• Allergy to porcine collagen
• Known allergy to adhesive bandage
• Autoimmune disease
• Uncontrolled metabolic diseases (e.g. diabetes, osteomalacia, thyroid disorder)
• Previous or planned prolonged corticosteroid therapy
• Insufficiently vascularized soft tissues due to heavy smoking
• Skin defect at target site(s) smaller than 10 mm in diameter
• Skin defect at target site(s) caused by burn or ulcer
• Chronical wound at target site(s)
• Local infection at target site(s)
• Known collagenase disease
• Previous or planned radiotherapy in the target area
• Immunosuppressive therapy
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study
• Vulnerable population
• Women of childbearing age who are not using a highly effective method of birth control
• Pregnant or breast feeding women
• Participation in another study with investigational drug, biologics or device within the 26 weeks preceding the present study
• Participation in another clinical study during the present study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the scar by means of POSAS Score (Patient and Observer Scar Assessment Scale) at 6 months.<br>The assessment comprises various parameters of functionality and appearance of the scar and is captured by means of a validated questionaire. The endpoint is the score derived from the assessment by the patient (50%) and by two physicians (50%).
- Secondary Outcome Measures
Name Time Method single parametrs of POSAS score