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Safety and Performance of SWIS in Superficial Wounds

Primary Purpose

Wound of Skin

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

SWIS

About this trial

This is an interventional prevention trial for Wound of Skin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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:

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

Sites / Locations

Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SoftOx Wound Irrigation Solution (SWIS)

Normal Saline

Arm Description

Blister wounds will be irrigated and soaked for 15 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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

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

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.

The incidence and severity of adverse events

Evaluate any differences between the two treatments regarding side effects

Full Information

NCT ID

NCT04771819

First Posted

November 23, 2020

Last Updated

October 16, 2021

Sponsor

SoftOx Solutions AS

1. Study Identification

Unique Protocol Identification Number

NCT04771819

Brief Title

Safety and Performance of SWIS in Superficial Wounds

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 16, 2020 (Actual)

Primary Completion Date

March 30, 2021 (Actual)

Study Completion Date

July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SoftOx Solutions AS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound of Skin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SoftOx Wound Irrigation Solution (SWIS)

Arm Type

Experimental

Arm Description

Blister wounds will be irrigated and soaked for 15 minutes.

Arm Title

Normal Saline

Arm Type

Active Comparator

Arm Description

Blister wounds will be irrigated and soaked for 15 minutes.

Intervention Type

Device

Intervention Name(s)

SWIS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound

Description

Measure the degree of re-epithelialization to evaluate any differences between the treatments.

Time Frame

From baseline to day 10

Secondary Outcome Measure Information:

Title

Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound.

Description

Evaluate any differences between the two treatments on early epithelialization.

Time Frame

From baseline to day 4

Title

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

Description

Evaluate any differences between the two treatments on day 10

Time Frame

Day 10

Title

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

Description

Evaluate any differences between the two treatments on day 17

Time Frame

Day 17

Title

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

Description

Evaluate any differences between the two treatments on reducing bacterial load in wounds

Time Frame

Day 4

Title

Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound

Description

Evaluate any differences on pain using VAS scale between the SWIS and Normal Saline during irrigation and moistening on day 0,2 and 4.

Time Frame

Baseline (day 0), day 2 and day 4

Title

The incidence and severity of adverse events

Description

Evaluate any differences between the two treatments regarding side effects

Time Frame

Baseline to day 17

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

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Safety and Performance of SWIS in Superficial Wounds

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