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

Primary Purpose

Phlebitis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nitroglycerin ointment
Clobetasol Topical
Sponsored by
Komar University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phlebitis focused on measuring Nitroglycerine, Clobetasol, phlebitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    nitroglycerin

    clobetasol

    routine

    Arm Description

    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.

    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.

    routine nursing care

    Outcomes

    Primary Outcome Measures

    Demographic information questionnaire
    age and type of disease

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 4, 2020
    Last Updated
    December 22, 2020
    Sponsor
    Komar University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04685031
    Brief Title
    Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis
    Acronym
    OT
    Official Title
    Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    April 1, 2021 (Anticipated)
    Study Completion Date
    May 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Komar University of Science and Technology

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Phlebitis
    Keywords
    Nitroglycerine, Clobetasol, phlebitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nitroglycerin
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    clobetasol
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    routine
    Arm Type
    No Intervention
    Arm Description
    routine nursing care
    Intervention Type
    Drug
    Intervention Name(s)
    Nitroglycerin ointment
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Clobetasol Topical
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Demographic information questionnaire
    Description
    age and type of disease
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    The visual scale of phlebitis
    Description
    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.
    Time Frame
    72hours

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis

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