Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds

Study Overview
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Brief Summary
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This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.

Detailed Description
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This is a pilot study with an open-label, exploratory study design with the aim to document preliminary safety and performance of the SoftOx Wound Irrigation Solution while used as intended by the manufacturer, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds. This first-in-man study will give valuable information on the feasibility of the treatment with the SoftOx Wound Irrigation Solution to prepare for continuous studies in clinically significant settings prior CE marking. The investigation population will consist of 12 subjects undergoing split skin graft transplantation for treating chronic leg ulcers and that are fulfilling the eligibility criteria for the clinical investigation. The SoftOx Wound Irrigation Solution will be applied on the donor site of the split skin graft which is a representative model of acute wounds in a controlled setting. All subjects will be followed up for 21 days. The duration of the investigation is estimated to 4 months.

Official Title
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Pilot Study to Document Safety and Performance of SoftOx Wound Irrigation Solution in Patients With Split Skin Wounds (Donor Site) Undergoing Skin Transplantation. A Human Model for Acute Trauma Wounds

Conditions
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Acute Wounds

Intervention / Treatment
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* Device: SoftOx Wound Irrigation Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation Been informed of the nature, the scope and the relevance of the clinical investigation Voluntarily agreed to participation and has duly signed the Informed Consent Form Exclusion Criteria: Participating in any other clinical investigation On systemic immunomodulating drugs On systemic steroid treatment up to four (4) weeks prior to study inclusion On strong pain medication (e.g. opioids) Severe neuropathy (or dysesthesia on the donor site) Pregnancy Dementia Allergy to polyurethane foam, 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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SoftOx Wound Irrigation Solution<br>SoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds. | Device: SoftOx Wound Irrigation Solution<br>* The SoftOx Wound Irrigation Solution is a Medical device that contains a combination of hypochlorous acid and acetic acid in purified water. SWIS is primary intended for mechanical irrigation of acute wounds whereas hypochlorous acid acts as a ancillary medicinal (drug) substance with potential antimicrobial effects. Acute wounds will be rinsed according to protocol and safety (AEs/ADEs/SAEs/SADEs) is the primary objective.<br>* Other names: SWIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution | Incidence and severity of any adverse events related to the SoftOx Wound Irrigation Solution will be summarized in terms of frequencies (n), percentages (%) and the mode. | Evaluation over 21 days |