Acute Wounds
Conditions
Brief summary
This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.
Detailed description
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.
Interventions
DEVICESoftOx Wound Irrigation Solution
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.
Sponsors
SoftOx Solutions AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older 2. Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation 3. Been informed of the nature, the scope and the relevance of the clinical investigation 4. Voluntarily agreed to participation and has duly signed the Informed Consent Form
Exclusion criteria
1. Participating in any other clinical investigation 2. On systemic immunomodulating drugs 3. On systemic steroid treatment up to four (4) weeks prior to study inclusion 4. On strong pain medication (e.g. opioids) 5. Severe neuropathy (or dysesthesia on the donor site) 6. Pregnancy 7. Dementia 8. Allergy to polyurethane foam, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| - The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution | Evaluation over 21 days | 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. |
Countries
Denmark
Contacts
Primary ContactEwa A Burian, MD
Outcome results
None listed