Bispebjerg Hospital
Copenhagen, Denmark
NCT Number: NCT04771819
This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to CE mark to confirm safety and performance of the SWIS device when used as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Copenhagen, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.
Time frame: From baseline to day 10
Measure the degree of re-epithelialization to evaluate any differences between the treatments.
Time frame: From baseline to day 4
Evaluate any differences between the two treatments on early epithelialization.
Time frame: Day 10
Evaluate any differences between the two treatments on day 10
Time frame: Day 17
Evaluate any differences between the two treatments on day 17
Time frame: Day 4
Evaluate any differences between the two treatments on reducing bacterial load in wounds
Time frame: Baseline (day 0), day 2 and day 4
Evaluate any differences on pain using VAS scale between the SWIS and Normal Saline during irrigation and moistening on day 0,2 and 4.
Time frame: Baseline to day 17
Evaluate any differences between the two treatments regarding side effects
SoftOx Solutions AS
Industry
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) Compared to Normal Saline (NS) in Human Experimental Suction Blister Wounds
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