Safety and Performance of SWIS in Superficial Wounds

Not Applicable

Completed

• Conditions: Wound of Skin
• Interventions: Device: SWIS

• Registration Number: NCT04771819
• Lead Sponsor: SoftOx Solutions AS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Primary Completion: 2021-03-30
• Study Completion: 2021-07-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-16
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SoftOx Wound Irrigation Solution (SWIS)	SWIS	Blister wounds will be irrigated and soaked for 15 minutes.
Normal Saline	SWIS	Blister wounds will be irrigated and soaked for 15 minutes.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark