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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04384679
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Hydrophilic polymer and potassium ferrate powder
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydrophilic polymer and potassium ferrate powder

Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved

Device: Hydrophilic polymer and potassium ferrate powder
Application with pressure until hemostasis is achieved
No Intervention: Direct pressure with sterile gauze

Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medicine New York New York United States 10021

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Shari R Lipner, MD, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT04384679
Other Study ID Numbers:
  • 20-02021562
First Posted:
May 12, 2020
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Weill Medical College of Cornell University
Nails
Nail Surgery
Hemostasis
Potassium Ferrate
Additional relevant MeSH terms:
Nail Diseases

Study Results

No Results Posted as of Aug 23, 2022