Wound of SkinNCT04771819
Safety and Performance of SWIS in Superficial Wounds
A study testing SWIS in people with Wound of Skin, run by SoftOx Solutions AS at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound of Skin
- What is being tested?
- SWIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Nov 2020to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wound of Skin
- Being tested
- SWIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWISDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SoftOx Wound Irrigation Solution (SWIS) | Experimental | Blister wounds will be irrigated and soaked for 15 minutes. Receives: Device: SWIS |
| Normal Saline | Active comparator | Blister wounds will be irrigated and soaked for 15 minutes. Receives: Device: SWIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Evaluate any differences between the two treatments on early epithelialization.
Measured: From baseline to day 4
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
Measured: 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
Measured: 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
Measured: 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
Evaluate any differences on pain using VAS scale between the SWIS and Normal Saline during irrigation and moistening on day 0,2 and 4.
Measured: Baseline (day 0), day 2 and day 4
The incidence and severity of adverse events
Evaluate any differences between the two treatments regarding side effects
Measured: Baseline to day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start16 Nov 2020
- Primary completion30 Mar 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SoftOx Solutions AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771819
- Sponsor's protocol ID
- SWIS-02
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds
- ClinicalTrials.gov ID
- NCT04771819
- Acronym / sponsor ID
- SWIS-02
- Conditions
- Wound of Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SoftOx Solutions ASIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoftOx Wound Irrigation Solution (SWIS) | Experimental | Device: SWISBlister wounds will be irrigated and soaked for 15 minutes. |
| Normal Saline | Active comparator | Device: SWISBlister wounds will be irrigated and soaked for 15 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWISBilateral 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. | Device | Normal Saline, SoftOx Wound Irrigation Solution (SWIS) |
Primary outcome
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.
6 secondary outcomes
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
Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound
Time frame: 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
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
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
The incidence and severity of adverse events
Time frame: Baseline to day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWIS in people with Wound of Skin, run by SoftOx Solutions AS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.