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

Sponsor
SoftOx Solutions AS (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03742284
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
7.1
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SoftOx Wound Irrigation Solution
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Nov 12, 2018
Anticipated Primary Completion Date :
May 31, 2019
Anticipated Study Completion Date :
Jun 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • SWIS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. - The incidence and severity of any adverse events associated with the SoftOx Wound Irrigation Solution [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Bispebjerg University Hospital Copenhagen Denmark 2400

    Sponsors and Collaborators

    • SoftOx Solutions AS

    Investigators

    • Principal Investigator: Ewa A Burian, MD, Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SoftOx Solutions AS
    ClinicalTrials.gov Identifier:
    NCT03742284
    Other Study ID Numbers:
    • CIV-18-08-025365
    First Posted:
    Nov 15, 2018
    Last Update Posted:
    Mar 5, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Mar 5, 2019