Trials / Completed
CompletedNCT06442865
AMNIODERM+ Medical Device Clinical Study
Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- BioHealing s.r.o. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMNIODERM+ | A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties. The product will be evaluated in the subjects not responding to SoC. |
Timeline
- Start date
- 2022-11-16
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
- First posted
- 2024-06-04
- Last updated
- 2024-06-05
Locations
1 site across 1 country: Slovakia
Source: ClinicalTrials.gov record NCT06442865. Inclusion in this directory is not an endorsement.