Safety and Performance of SWIS in Superficial Wounds

• ClinicalTrials.gov Identifier: NCT04771819
• Recruitment Status: Completed
• First Posted: February 25, 2021
• Last Update Posted: October 19, 2021
• Sponsor: SoftOx Solutions AS
• Information provided by (Responsible Party): SoftOx Solutions AS

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Wound of Skin	Device: SWIS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds
• Actual Study Start Date: November 16, 2020
• Actual Primary Completion Date: March 30, 2021
• Actual Study Completion Date: July 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: SoftOx Wound Irrigation Solution (SWIS); Blister wounds will be irrigated and soaked for 15 minutes.	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.
Active Comparator: Normal Saline; Blister wounds will be irrigated and soaked for 15 minutes.	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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Denmark

Bispebjerg Hospital

Copenhagen, Denmark

Sponsors and Collaborators

SoftOx Solutions AS

More Information

• Responsible Party: SoftOx Solutions AS
• ClinicalTrials.gov Identifier: NCT04771819
• Other Study ID Numbers: SWIS-02
• First Posted: February 25, 2021
• Last Update Posted: October 19, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Wounds and Injuries