Benefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery

Nail Diseases Clinical Trial

Official title:

The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04384679
• Other study ID #: 20-02021562
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nail Diseases

Intervention

Device:
• Hydrophilic polymer and potassium ferrate powder
Application with pressure until hemostasis is achieved

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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)