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

August 22, 2022 updated by: Weill Medical College of Cornell University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Frame: Baseline
Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with at least one adverse event
Time Frame: End of study (28 days)
Adverse events will only include those that are determined to be related to the study device
End of study (28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-02021562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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