Back to resultsBenefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
Primary Purpose
Nail Diseases
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydrophilic polymer and potassium ferrate powder
Sponsored by
About this trial
This is an interventional supportive care trial for Nail Diseases focused on measuring Nails, Nail Surgery, Hemostasis, Potassium Ferrate
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hydrophilic polymer and potassium ferrate powder
Direct pressure with sterile gauze
Arm Description
Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved
Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04384679
First Posted
May 8, 2020
Last Updated
August 22, 2022
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04384679
Brief Title
Benefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
Official Title
The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to reallocation of resources, this study could not be initiated.
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Diseases
Keywords
Nails, Nail Surgery, Hemostasis, Potassium Ferrate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrophilic polymer and potassium ferrate powder
Arm Type
Experimental
Arm Description
Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved
Arm Title
Direct pressure with sterile gauze
Arm Type
No Intervention
Arm Description
Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved
Intervention Type
Device
Intervention Name(s)
Hydrophilic polymer and potassium ferrate powder
Intervention Description
Application with pressure until hemostasis is achieved
Primary Outcome Measure Information:
Title
Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze
Description
Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of participants with at least one adverse event
Description
Adverse events will only include those that are determined to be related to the study device
Time Frame
End of study (28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari R Lipner, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Benefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
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