Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients
NCT05618496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2024-02-08
Summary
The main objective of the trial is to confirm safety of a new product - Epipad. The main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).
Conditions
- Wound
Interventions
- DEVICE
-
Sodium Hyaluronate Lyophilizate
Device is placed directly onto the treated wound. The wound should be cleaned with antiseptic solution prior to the device administration. The device is fixed on the wound by secondary dressing: e.g. plaster, compression.
Sponsors & Collaborators
-
Contipro Pharma a.s.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-26
- Primary Completion
- 2023-10-31
- Completion
- 2023-10-31
Countries
- Czechia
Study Locations
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