Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds (SWIS-01)
Primary Purpose
Acute Wounds
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SoftOx Wound Irrigation Solution
Sponsored by
About this trial
This is an interventional other trial for Acute Wounds
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Bispebjerg University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SoftOx Wound Irrigation Solution
Arm Description
SoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds.
Outcomes
Primary Outcome Measures
- 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03742284
Brief Title
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds
Acronym
SWIS-01
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
June 15, 2019 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Wounds
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SoftOx Wound Irrigation Solution
Arm Type
Other
Arm Description
SoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds.
Intervention Type
Device
Intervention Name(s)
SoftOx Wound Irrigation Solution
Other Intervention Name(s)
SWIS
Intervention Description
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.
Primary Outcome Measure Information:
Title
- The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution
Description
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.
Time Frame
Evaluation over 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewa A Burian, MD
Phone
+45 53 60 91 59
Email
ewa.anna.burian@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa A Burian, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa A Burian, MD
Email
ewa.anna.burian@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds
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