Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis (OT)

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.

Study Overview

• Status: Unknown
• Conditions: Phlebitis
• Intervention / Treatment: Drug: Nitroglycerin ointment; Drug: Clobetasol Topical

Detailed Description

Aim: 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.

Background: Today, more than 80 to 90% of hospitalized patients receive intravenous treatment during their treatment, and more than 500 million peripheral venous catheters are placed annually, although cannulation provide numerous benefits in clinical setting, but because of its invasive feature, it can end in unpleasant outcomes such as phlebitis Method: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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....)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nitroglycerin; 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 ointment; 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: Clobetasol Topical; 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.
Experimental: clobetasol; 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 ointment; 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: Clobetasol Topical; 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.
No Intervention: routine; routine nursing care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic information questionnaire	age and type of disease	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The visual scale of phlebitis	The visual scale of phlebitis is as follows: Grade 0: no clinical symptoms, Grade 1: pain or redness, Grade 2: pain, redness or edema at the site, unclear vein boundaries, no rope vein in touch, Grade 3: pain, redness or edema at the site, clear blood vessels, no rope vein in touch, Grade 4: the presence of pain and erythema or edema at the site, the clearness of the arteries and the rope vein in touch.	72hours

Collaborators and Investigators

• Sponsor: Komar University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: phlebitis; Clobetasol; Nitroglycerine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis; Peripheral Vascular Diseases; Phlebitis; Physiological Effects of Drugs; Vasodilator Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitroglycerin; Clobetasol
• Other Study ID Numbers: KomarUST

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: No
• product manufactured in and exported from the U.S.: No