Trials / Completed
CompletedNCT04771819
Safety and Performance of SWIS in Superficial Wounds
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- SoftOx Solutions AS · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to CE mark to confirm safety and performance of the SWIS device when used as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SWIS | Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator. |
Timeline
- Start date
- 2020-11-16
- Primary completion
- 2021-03-30
- Completion
- 2021-07-20
- First posted
- 2021-02-25
- Last updated
- 2021-10-19
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04771819. Inclusion in this directory is not an endorsement.