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
About this trial
This is an interventional prevention trial for Phlebitis focused on measuring Nitroglycerine, Clobetasol, phlebitis
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
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
NCT ID
NCT04685031
First Posted
December 4, 2020
Last Updated
December 22, 2020
Sponsor
Komar University of Science and Technology
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
Learn more about this trial
Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis
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