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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SoftOx Wound Irrigation Solution (SWIS) | Experimental | Blister wounds will be irrigated and soaked for 15 minutes. |
|
| Normal Saline | Active Comparator | Blister wounds will be irrigated and soaked for 15 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SWIS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to day 4 |
| Percentage of suction blister wounds healed on day 10 in the SWIS treated wound versus NS treated wound |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | Denmark |
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Evaluate any differences between the two treatments on day 10 |
| 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 | 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 | 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. | Baseline (day 0), day 2 and day 4 |
| The incidence and severity of adverse events | Evaluate any differences between the two treatments regarding side effects | Baseline to day 17 |