NCT04685031

Brief Summary

The aim of this study was to determine the effect of Clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation. This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of Clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_1

Status
unknown

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

December 4, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 4, 2020

Last Update Submit

December 22, 2020

Conditions

Keywords

NitroglycerineClobetasolphlebitis

Outcome Measures

Primary Outcomes (1)

  • Demographic information questionnaire

    age and type of disease

    72 hours

Secondary Outcomes (1)

  • The visual scale of phlebitis

    72hours

Study Arms (3)

nitroglycerin

EXPERIMENTAL

after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

Drug: Nitroglycerin ointmentDrug: Clobetasol Topical

clobetasol

EXPERIMENTAL

after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

Drug: Nitroglycerin ointmentDrug: Clobetasol Topical

routine

NO INTERVENTION

routine nursing care

Interventions

after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

clobetasolnitroglycerin

after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

clobetasolnitroglycerin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • must be older than 18 years old
  • must be in need of hospitalization at least 72 hours
  • does not state any previous allergic reaction to the ointments
  • does not use any types of drug that can hurts veins (chemotherapy drugs, diazepam. amiodarone, and....)

You may not qualify if:

  • active infection
  • discharge from hospital sooner than 72 hours
  • displacement of cannula before 72 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Phlebitis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator,nursing department

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 28, 2020

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share