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Due to reallocation of resources, this study could not be initiated.
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The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrophilic polymer and potassium ferrate powder | Experimental | Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved |
|
| Direct pressure with sterile gauze | No Intervention | Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrophilic polymer and potassium ferrate powder | Device | Application with pressure until hemostasis is achieved |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze | Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with at least one adverse event | Adverse events will only include those that are determined to be related to the study device | End of study (28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari R Lipner, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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