Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds (SWIS-01)
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|ClinicalTrials.gov Identifier: NCT03742284|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Wounds||Device: SoftOx Wound Irrigation Solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- - 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742284
|Contact: Ewa A Burian, MD||+45 53 60 91 firstname.lastname@example.org|
|Bispebjerg University Hospital||Recruiting|
|Copenhagen, Denmark, 2400|
|Contact: Ewa A Burian, MD email@example.com|
|Principal Investigator:||Ewa A Burian, MD||Bispebjerg Hospital|