Safety and Performance of SWIS in Superficial Wounds

October 16, 2021 updated by: SoftOx Solutions AS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From baseline to day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From baseline to day 4
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
Day 10
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
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
Time Frame: Day 4
Evaluate any differences between the two treatments on reducing bacterial load in wounds
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
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.
Baseline (day 0), day 2 and day 4
The incidence and severity of adverse events
Time Frame: Baseline to day 17
Evaluate any differences between the two treatments regarding side effects
Baseline to day 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SoftOx Solutions AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWIS-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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