Safety and Performance of SWIS in Superficial Wounds

Wound of Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771819
• Other study ID #: SWIS-02
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: July 20, 2021

Study information

• Verified date: October 2021
• Source: SoftOx Solutions AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 20, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound of Skin
• Wounds and Injuries

Intervention

Device:
• SWIS
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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
SoftOx Solutions AS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The incidence and severity of adverse events	Evaluate any differences between the two treatments regarding side effects	Baseline to day 17