surgical skin lesion
Conditions
Interventions
Group 1: Postexcisional treatment of skin lesions with the collagen matrix Geistlich Wound Matrix
Group 2: Postexcisional treatment of skin lesions by
autologous skin grafting
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the scar by means of POSAS Score (Patient and Observer Scar Assessment Scale) at 6 months. 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
| Measure | Time frame |
|---|---|
| single parametrs of POSAS score | — |
Countries
Germany, Switzerland
Contacts
Public ContactMarco Nief
Geistlich Pharma AG
Outcome results
None listed