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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
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.
Bispebjerg Hospital
Copenhagen, Denmark
Degree (percentage) re-epithelialization in the suction blister wound on day 10 in the SWIS treated wound versus NS treated wound
Measure the degree of re-epithelialization to evaluate any differences between the treatments.
Time frame: From baseline to day 10
Degree (percentage) re-epithelialization in the suction blister wound on day 4 in the SWIS treated wound versus NS treated wound.
Evaluate any differences between the two treatments on early epithelialization.
Time frame: From baseline to day 4
Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound
Evaluate any differences between the two treatments on day 10
Time frame: Day 10
Percentage of suction blister wounds healed on day 17 (+/- 1 day) in the SWIS treated wound versus NS treated wound
Evaluate any differences between the two treatments on day 17
Time frame: Day 17
Percentage of suction blister wounds with >30% CFU reduction in the SWIS treated wound and NS treated wound respectively if positive CFU level prior irrigation
Evaluate any differences between the two treatments on reducing bacterial load in wounds
Time frame: Day 4
Subject evaluation of pain during each irrigation procedure on days 0, 2 and 4 in the SWIS treated wound versus NS treated wound
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 (day 0), day 2 and day 4
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The incidence and severity of adverse events
Evaluate any differences between the two treatments regarding side effects
Time frame: Baseline to day 17