Clinical trial NCT04771819: Safety and Performance of SWIS in Superficial Wounds
Official title: Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound of Skin
Lead sponsor: SoftOx Solutions AS
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

1. Participating in any other clinical investigation
2. 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
3. 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
4. Daily smoker
5. Pregnancy
6. Systemic immunosuppressive treatment
7. Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator
8. Allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
9. Not able to read or understand Danish
10. Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
11. That according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Primary outcomes:
measure: Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound
timeFrame: From baseline to day 10
Secondary outcomes:
measure: Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound.
timeFrame: From baseline to day 4
measure: Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound
timeFrame: Day 10
measure: Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound
timeFrame: Day 17
measure: Percentage of suction blister wounds with >30% CFU reduction in the SWIS treated wound and NS treated wound respectively if positive CFU level prior irrigation
timeFrame: Day 4
measure: Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound
timeFrame: Baseline (day 0), day 2 and day 4
measure: The incidence and severity of adverse events
timeFrame: Baseline to day 17
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References: