Status:
COMPLETED
Safety and Performance of SWIS in Superficial Wounds
Lead Sponsor:
SoftOx Solutions AS
Conditions:
Wound of Skin
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Healthy and intact skin where the blister suction wounds will be induced
- Been informed of the nature, the scope and the relevance of the clinical investigation
- Voluntarily agreed to participation and has duly signed the Information Consent Form
Exclusion
- Participating in any other clinical investigation
- Disease that may interfere with the wound healing, e.g. diabetes, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema of the arm, severe obesity, severe psychiatric disease, dementia or previous known wound healing problems, as judged by the investigator
- Active skin disease, e.g. dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator
- Daily smoker
- Pregnancy
- Systemic immunosuppressive treatment
- Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator
- Allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
- Not able to read or understand Danish
- Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
- That according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04771819
Start Date
November 16 2020
End Date
July 20 2021
Last Update
October 19 2021
Active Locations (1)
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1
Bispebjerg Hospital
Copenhagen, Denmark