| Registry | NCT03020446, acronym Sorbion |
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| Status | Terminated - Provider of product no longer wished to continue with site. No data available. |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 3 (Actual) |
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| Sponsor | University of Toledo Health Science Campus (Other) |
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| Conditions | Venous Wound Ulcers |
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| Interventions | Sorbion Dressing (Device) |
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| Dates | start 2014-07-01, primary completion 2016-03-01, completion 2016-03-01, first posted 2017-01-13, last updated 2020-11-27 |
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| Locations | 1 site in United States |
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All trials for Venous Wound Ulcers All trials of Sorbion Dressing
-Summary
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
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+Detailed description
Wounds will be assessed for inclusion into the study, digital images of the wound will be taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover dressing with be used to keep in place. The wound will be assessed and a dressing change will take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Sorbion dressing to venous leg ulcer | Experimental | Device: Sorbion Dressing | any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed |
- Sorbion Dressing (Device), also known as Sorbion Sachet sorbion sana: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
+Outcome measures
Primary outcomes
- Wound Size [4 weeks]: decreased wound bed measured in centimeters
Secondary outcomes
- Wound Maceration [4 weeks]: visual assessment of decreased wound maceration
- Wound Necrosis [4 weeks]: visual assessment of decreased wound necrosis
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* venous leg ulcer
Exclusion Criteria:
* pregnant females
+Posted results
Participant flow
| Milestone | Sorbion Dressing to Venous Leg Ulcer |
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| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
Outcome results
- Wound Size (Primary)
- Wound Maceration (Secondary)
- Wound Necrosis (Secondary)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Sorbion Dressing to Venous Leg Ulcer | 0/3 (0.0%) | 0/3 (0.0%) | 0/3 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| University of Toledo Medical Center | Toledo, Ohio | United States | |