Safety and Performance of SWIS in Superficial Wounds

NCT04771819 | Completed DMC

• 1 other identifier: SWIS-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound of Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound

  Day 10

• Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound

  Day 17

• 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

• 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

Study Arms (2)

SoftOx Wound Irrigation Solution (SWIS)

EXPERIMENTAL

Blister wounds will be irrigated and soaked for 15 minutes.

Device: SWIS

Normal Saline

ACTIVE COMPARATOR

Blister wounds will be irrigated and soaked for 15 minutes.

Device: SWIS

Interventions

SWIS DEVICE

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.

Normal Saline; SoftOx Wound Irrigation Solution (SWIS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participating in any other clinical investigation
• 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
• 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
• Daily smoker
• Pregnancy
• Systemic immunosuppressive treatment
• Uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator
• Allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation
• Not able to read or understand Danish
• Any other conditions that as judged by the investigator may make follow-up or investigation inappropriate
• That according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Sponsors & Collaborators

• SoftOx Solutions AS: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: February 25, 2021
• Study Start: November 16, 2020
• Primary Completion: March 30, 2021
• Study Completion: July 20, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)