Trials / Recruiting
RecruitingNCT07312513
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- Lohmann & Rauscher · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
Detailed description
This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.
Conditions
- Diabetic Ulcers
- Arterial Ulcers
- Venous Ulcers
- Pressure Ulcers
- Postoperative Wounds Healing by Secondary Intention
- Burns and Scalds
- Epidermolysis Bullosa (EB)
- Traumatic Wounds
- Surgical Wounds
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | two sided debridement pad | two sided debridement pad |
| DEVICE | one sided debridment pad | one sided debridment pad |
Timeline
- Start date
- 2025-05-09
- Primary completion
- 2026-02-01
- Completion
- 2026-02-01
- First posted
- 2025-12-31
- Last updated
- 2025-12-31
Locations
5 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT07312513. Inclusion in this directory is not an endorsement.