Non-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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014991

Enrollment

Registered

2018-06-26

Start date

2018-06-20

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

surgical skin defect

Interventions

Group 1: Geistlich Wound Matrix treated patients Group 2: autologous skin graft treated patients

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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%).	—

Measure

Time frame

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

Measure	Time frame
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).	—

Countries

Germany

Contacts

Public ContactMarco Nief

Geistlich Pharma AG

marco.nief@geistlich.ch+41 41 492 56 72

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026