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Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds (SWIS-01)

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ClinicalTrials.gov Identifier: NCT03742284
Recruitment Status : Unknown
Verified March 2019 by SoftOx Solutions AS.
Recruitment status was:  Recruiting
First Posted : November 15, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
SoftOx Solutions AS

Study Description
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Brief Summary:
This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.

Condition or disease Intervention/treatment Phase
Acute Wounds Device: SoftOx Wound Irrigation Solution Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 15, 2019

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Arms and Interventions
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Arm Intervention/treatment
SoftOx Wound Irrigation Solution
SoftOx Wound Irrigation Solution is Medical Device that will be applied to rinse acute wounds.
 Device: SoftOx Wound Irrigation Solution

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.

Other Name: SWIS


Outcome Measures
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Primary Outcome Measures :
  1. - 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 and older
  2. Non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation
  3. Been informed of the nature, the scope and the relevance of the clinical investigation
  4. Voluntarily agreed to participation and has duly signed the Informed Consent Form

Exclusion Criteria:

  1. Participating in any other clinical investigation
  2. On systemic immunomodulating drugs
  3. On systemic steroid treatment up to four (4) weeks prior to study inclusion
  4. On strong pain medication (e.g. opioids)
  5. Severe neuropathy (or dysesthesia on the donor site)
  6. Pregnancy
  7. Dementia
  8. Allergy to polyurethane foam, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742284


Contacts
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Contact: Ewa A Burian, MD +45 53 60 91 59 ewa.anna.burian@regionh.dk

Locations
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Denmark
Bispebjerg University Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Ewa A Burian, MD       ewa.anna.burian@regionh.dk   
Sponsors and Collaborators
SoftOx Solutions AS
Investigators
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Principal Investigator: Ewa A Burian, MD Bispebjerg Hospital
More Information
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Responsible Party: SoftOx Solutions AS
ClinicalTrials.gov Identifier: NCT03742284    
Other Study ID Numbers: CIV-18-08-025365
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries