Safety and Performance of SWIS in Superficial Wounds

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds

Conditions
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Wound of Skin

Intervention / Treatment
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* Device: SWIS


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SoftOx Wound Irrigation Solution (SWIS)<br>Blister wounds will be irrigated and soaked for 15 minutes. | Device: SWIS<br>* 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.<br>|
| Active Comparator: Normal Saline<br>Blister wounds will be irrigated and soaked for 15 minutes. | Device: SWIS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound | Measure the degree of re-epithelialization to evaluate any differences between the treatments. | From baseline to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound. | Evaluate any differences between the two treatments on early epithelialization. | From baseline to day 4 | 
| Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound | Evaluate any differences between the two treatments on day 10 | Day 10 | 
| Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound | Evaluate any differences between the two treatments on day 17 | Day 17 | 
| 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 | Evaluate any differences between the two treatments on reducing bacterial load in wounds | Day 4 | 
| Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound | Evaluate any differences on pain using VAS scale between the SWIS and Normal Saline during irrigation and moistening on day 0,2 and 4. | Baseline (day 0), day 2 and day 4 | 
| The incidence and severity of adverse events | Evaluate any differences between the two treatments regarding side effects | Baseline to day 17 |