Effect of Skin Antisepsis on Phlebitis

NCT04817020 | Completed

• 1 other identifier: AKeskin
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief Summary

Peripheral intravenous catheters have application such as fluid, blood, medication and feding fluids. Although it is a life-savingtool, it can lead to some complications as a result of incorrect applications. Phlebitis, which is defined as inflammation of the tunica intima layer of the vein, is characterized by pain, redness, tenderness, palpable stiffness and increased temperature. As can be seen during catheter application, it can develop within 48-96 hours after catheter removal. Instudies performed, the rate of phlebitis development was 0.1-63.3% in patients with peripheral intravenous catheters, in Turkey, this rate varies between 11% and 67%. Phlebitis; can be originated mechanical, chemical and bacterial. Various guidelines are available from evidence based on research results to prevent and reduce phlebitis development. In our country, National Vascular Access Management Guide is used. One of the principles in the National Guidelines for Vascular Access Management for the prevention of phlebitis is skin antisepsis. The guideline recommends a 70% alcohol solution containing\>0.5% chlorhexidine for skin antisepsis and reports that povidone-iodine or only 70% alcohol solution can be used in the absence or contraindication. Infusion Nurses Society (INS, 2016) recommends using the 'Phlebitis Scale' in the early diagnosis of phlebitis. In this study, investigator aimed to compare the antiseptic effects of 2% chlorhexidine and 70% alcohol which are used as antiseptic in preventing phlebitis development while providing skin antisepsis, which is one of the basic principles in the application of peripheral intravenous catheter. This study is a randomized controlled clinical study and the population will consist of patients (participants)hospitalized in the Surgery -1 Department of Balcalı Hospital, Faculty of Medicine, Çukurova University. As a data collection tool; 'Patient Information Form' and 'İnformation Form for İntravenous Catheter Application to the Patient' created by there searcher, to evaluate phlebitis formation "Phlebitis Scale'' which published by the Infusion Nurses Society (INS, 2016) will be used. A transparent millimeter ruler will be used

Conditions

Phlebitis

Outcome Measures

Primary Outcomes (3)

• Patient information form

  The "Patient Information Form" created by the researcher using the literature consists of 15 questions. Demographic information of the patient (diagnosis, age, gender, weight, height, body mass index, chronic disease, alcohol, smoking, allergy, edema in hands and feet) and intravenous drugs and these drugs It consists of questions that give information about how it is done.

  5 minute

• Information Form Regarding the Application of the IV Catheter to the Patient

  In the form created by the researcher by scanning the literature, the date and time of the intravenous catheter insertion and removal, the size of the catheter, the area where the catheter was inserted, the number of trials the catheter was inserted, and the precaution package to be applied during catheter insertion published by the National Vascular Access Management Guide (2019) There are questions created by using the catheter, guiding the person wearing the catheter and giving information about what kind of antisepsis was performed during the insertion of the catheter.

  30 minute

• Phlebitis Scale

  The phlebitis scale developed by the Infusion Nurses Society (INS, 2006) and recommended for use all over the world was used to determine the development status and degree of phlebitis.

  72 hours

Study Arms (2)

Klorheksidin

EXPERIMENTAL

Deri antisepsisi, vasküler erişimden önce chlorhexidine kullanılarak yapılacaktır

Other: %2 Klorheksidin

Alkol

EXPERIMENTAL

Skin antisepsis will be performed using alcohol prior to vascular access

Other: %2 Klorheksidin

Interventions

%2 Klorheksidin OTHER

Effect on phlebitis

Also known as: % 70 Alchol

Alkol; Klorheksidin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-65, Patients who accept the study,
• Patients newly admitted to the clinic,
• Patients whose vascular access will be opened in the clinic,
• Patients whose upper extremity can be used for vascular access, Patients not receiving chemotherapy, Patients using antibiotics and analgesics containing the same active substance in intravenous drug treatment, Patients not discharged before 72 hours,
• Patients without blood disease, Patients without peripheral vascular disease,

You may not qualify if:

• Patients younger than 18 and older than 65, Patients who do not accept the study, Patients with peripheral vascular disease, Patients with blood disease, Patients receiving chemotherapy,
• Patients who do not use the upper extremity,

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (2)

Çukurova üniversitesi sağlık bilimleri fakültesi

Adana, Sarıçam, Turkey (Türkiye)

Location

Çukurova university

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Randomize,controlled double-blind clinical trials

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: January 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 16, 2021
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

TU (2)