Acute WoundsSWIS-01NCT03742284
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds
A study testing SoftOx Wound Irrigation Solution in people with Acute Wounds, run by SoftOx Solutions AS at 1 site in Denmark.
Trial summary
This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Wounds
- What is being tested?
- SoftOx Wound Irrigation Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2018to 15 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation
- Been informed of the nature, the scope and the relevance of the clinical investigation
- Voluntarily agreed to participation and has duly signed the Informed Consent Form
Who cannot join
- Participating in any other clinical investigation
- On systemic immunomodulating drugs
- On systemic steroid treatment up to four (4) weeks prior to study inclusion
- On strong pain medication (e.g. opioids)
- Severe neuropathy (or dysesthesia on the donor site)
- Pregnancy
Show all 11Show fewer
- Dementia
- Allergy to polyurethane foam, 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.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg University Hospital
Copenhagen, 2400
Ewa A Burian, MD, ewa.anna.burian@regionh.dk
About this study
Official title: Pilot Study to Document Safety and Performance of SoftOx Wound Irrigation Solution in Patients With Split Skin Wounds (Donor Site) Undergoing Skin Transplantation. A Human Model for Acute Trauma Wounds
This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.
Read the detailed description
This is a pilot study with an open-label, exploratory study design with the aim to document preliminary safety and performance of the SoftOx Wound Irrigation Solution while used as intended by the manufacturer, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds. This first-in-man study will give valuable information on the feasibility of the treatment with the SoftOx Wound Irrigation Solution to prepare for continuous studies in clinically significant settings prior CE marking. The investigation population will consist of 12 subjects undergoing split skin graft transplantation for treating chronic leg ulcers and that are fulfilling the eligibility criteria for the clinical investigation. The SoftOx Wound Irrigation Solution will be applied on the donor site of the split skin graft which is a representative model of acute wounds in a controlled setting. All subjects will be followed up for 21 days. The duration of the investigation is estimated to 4 months.
- Conditions
- Acute Wounds
- Being tested
- SoftOx Wound Irrigation Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftOx Wound Irrigation SolutionDevice
Also called SWIS
The SoftOx Wound Irrigation Solution is a Medical device that contains a combination of hypochlorous acid and acetic acid in purified water. SWIS is primary intended for mechanical irrigation of acute wounds whereas hypochlorous acid acts as a ancillary medicinal (drug) substance with potential antimicrobial effects.
Acute wounds will be rinsed according to protocol and safety (AEs/ADEs/SAEs/SADEs) is the primary objective.
| Study group | Role | What they receive |
|---|---|---|
| SoftOx Wound Irrigation Solution | Other | SoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds. Receives: Device: SoftOx Wound Irrigation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
- The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution
Incidence and severity of any adverse events related to the SoftOx Wound Irrigation Solution will be summarized in terms of frequencies (n), percentages (%) and the mode.
Measured: Evaluation over 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start12 Nov 2018
- Primary completion31 May 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute WoundsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoftOx Solutions AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ewa A Burian, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742284
- Sponsor's protocol ID
- CIV-18-08-025365
- Acronym
- SWIS-01
- Status last verified
- Mar 2019
- First submitted
- 12 Nov 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Document Safety and Performance of SoftOx Wound Irrigation Solution in Patients With Split Skin Wounds (Donor Site) Undergoing Skin Transplantation. A Human Model for Acute Trauma Wounds
- ClinicalTrials.gov ID
- NCT03742284
- Acronym / sponsor ID
- SWIS-01 / CIV-18-08-025365
- Conditions
- Acute Wounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SoftOx Solutions ASIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 15 Nov 2018 (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 pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.
Detailed description
This is a pilot study with an open-label, exploratory study design with the aim to document preliminary safety and performance of the SoftOx Wound Irrigation Solution while used as intended by the manufacturer, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds. This first-in-man study will give valuable information on the feasibility of the treatment with the SoftOx Wound Irrigation Solution to prepare for continuous studies in clinically significant settings prior CE marking. The investigation population will consist of 12 subjects undergoing split skin graft transplantation for treating chronic leg ulcers and that are fulfilling the eligibility criteria for the clinical investigation. The SoftOx Wound Irrigation Solution will be applied on the donor site of the split skin graft which is a representative model of acute wounds in a controlled setting. All subjects will be followed up for 21 days. The duration of the investigation is estimated to 4 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SoftOx Wound Irrigation Solution | Other | Device: SoftOx Wound Irrigation SolutionSoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and older
- Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation
- Been informed of the nature, the scope and the relevance of the clinical investigation
- Voluntarily agreed to participation and has duly signed the Informed Consent Form
Key exclusion criteria (11 listed)
- Participating in any other clinical investigation
- On systemic immunomodulating drugs
- On systemic steroid treatment up to four (4) weeks prior to study inclusion
- On strong pain medication (e.g. opioids)
- Severe neuropathy (or dysesthesia on the donor site)
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 |
|---|---|---|
| SoftOx Wound Irrigation SolutionAlso: SWISThe SoftOx Wound Irrigation Solution is a Medical device that contains a combination of hypochlorous acid and acetic acid in purified water. SWIS is primary intended for mechanical irrigation of acute wounds whereas hypochlorous acid acts as a ancillary medicinal (drug) substance with potential antimicrobial effects. Acute wounds will be rinsed according to protocol and safety (AEs/ADEs/SAEs/SADEs) is the primary objective. | Device | SoftOx Wound Irrigation Solution |
Primary outcome
- The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution
Time frame: Evaluation over 21 days
Incidence and severity of any adverse events related to the SoftOx Wound Irrigation Solution will be summarized in terms of frequencies (n), percentages (%) and the mode.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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.
Ewa A Burian, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoftOx Wound Irrigation Solution in people with Acute Wounds, 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 4 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: status not confirmed, as of the sponsor's last update on 5 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ewa A Burian, MD (+45 53 60 91 59, ewa.anna.burian@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution (time frame: Evaluation over 21 days). 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 5 Mar 2019.