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Open label study part reduced from n=10 to n=6 because of insufficient number of patients under antiaggregation.
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| Name | Class |
|---|---|
| Marine Polymer Technologies, Inc. | INDUSTRY |
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Background: The wound healing promoting effect of negative wound pressure therapies (NWPT) takes place at the wound foam interface. Implementation of bioactive substances at this site represents a major research area for the development of future NWPT devices.
Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine nanofibers (sNAG) was studied in a prospective randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wound dressing with VAC | Sham Comparator | After wound debridement wounds are treated for 2 weeks with VAC dressing alone |
|
| wound dressing with VAC and sNAG under Antiaggregation | Other | In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG |
|
| wound dressing with VAC and sNAG without antiaggregation | Experimental | In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wound dressing with VAC and sNAG without antiaggregation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 1 year | |
| Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing characteristics | Evaluation of granulation tissue formation in study groups | up to 1 year |
| Wound Healing characteristics | Evaluation of wound epithelialization in study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk J. Schaefer, Prof.Dr. | University Hospital, Basel, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland | |||
| Swiss Paraplegic Centre Nottwil |
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| wound dressing with VAC | Procedure |
|
| wound dressing with VAC and sNAG under Antiaggregation | Drug |
|
| up to 1 year |
| Wound Healing characteristics | Evaluation of wound contraction in study groups | up to 1 year |
| Nottwil |
| 6207 |
| Switzerland |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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