Nail Diseases
Conditions
Keywords
Nails, Nail Surgery, Hemostasis, Potassium Ferrate
Brief summary
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
Interventions
DEVICEHydrophilic polymer and potassium ferrate powder
Application with pressure until hemostasis is achieved
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * Patients scheduled for any type of nail surgical procedure * Willingness to participate in the study * Ability to understand all instructions in the English language
Exclusion criteria
* Failure to have nail surgery performed * Likely inability to comply with the study protocol or cooperate fully with the research team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze | Baseline | Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with at least one adverse event | End of study (28 days) | Adverse events will only include those that are determined to be related to the study device |
Countries
United States
Outcome results
None listed