NCT04384679

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

May 8, 2020

Last Update Submit

August 22, 2022

Conditions

Nail Diseases

Keywords

NailsNail SurgeryHemostasisPotassium Ferrate

Outcome Measures

Primary Outcomes (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

    Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation

    Baseline

Secondary Outcomes (1)

  • Number of participants with at least one adverse event

    End of study (28 days)

Study Arms (2)

Hydrophilic polymer and potassium ferrate powder

EXPERIMENTAL

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

Direct pressure with sterile gauze

NO INTERVENTION

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

Interventions

Hydrophilic polymer and potassium ferrate powderDEVICE

Application with pressure until hemostasis is achieved

Hydrophilic polymer and potassium ferrate powder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Failure to have nail surgery performed
  • Likely inability to comply with the study protocol or cooperate fully with the research team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Nail Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shari R Lipner, MD, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 12, 2020

Study Start

June 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)