Safety and Performance of SWIS in Superficial Wounds

SoftOx Solutions

Status: Completed

Conditions: Wound of Skin

Treatments: Device: SWIS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04771819

SWIS-02

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

SoftOx Wound Irrigation Solution (SWIS)

Experimental group

Description:

Blister wounds will be irrigated and soaked for 15 minutes.

Treatment:

Device: SWIS

Normal Saline

Active Comparator group

Description:

Blister wounds will be irrigated and soaked for 15 minutes.

Treatment:

Device: SWIS