Effect of Skin Antisepsis on Phlebitis

NCT ID: NCT04817020

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-10-16

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

Detailed Description

In the study, data were collected for 9 months between January 2020 and September 2020.

Before starting the research, the nurses in the clinic were informed about the work to be done. Participants who were admitted to the surgical service, who met the inclusion criteria and accepted to participate in the study on a voluntary basis were separated into two groups by block randomization method. Then, the participants assigned to the groups were informed about the study and the "Patient Information Form" was administered by the researcher after obtaining the consent of the individuals.

In order to eliminate the bias regarding the antiseptic used while inserting the catheter, investigator did not have information about the solution used, participants and nurses in the clinic. The solutions were prepared by the nurse in charge of the Surgery 1 Clinic. Both solutions were put into bottles of the same color and size. It was a light proof bottle in both bottles. The usage dates of both solutions were checked. As they were transferred to different bottles, the bottles and solutions were renewed once a month by the nurse in charge with the recommendation of the hospital infection control committee. A pink sticker was attached to one of the bottles (to cover the entire bottle), and a blue sticker to the other (to cover the entire bottle). Which color and which solution was known only by the clinic responsible nurses.

As stated in the statement of the nurse in charge of the surgery 1 service, he wrote the color which solution was on a piece of paper and put it in a sealed envelope. D He prepared two of the same envelopes and gave the other one to the responsible nurse of the General Surgery-2 Clinic. The envelopes were kept by both responsible until the end of the work. Solutions could not be distinguished in terms of color and odor. After the study comes from statistics, when looking at the solutions by opening the closed envelope; It was observed that 2% chlorhexidine was used in the participants in group 1 (blue solution) selected by randomization method, and 70% alcohol was used in the second group (pink solution) by investigator.İ.V. A sterile, transparent, semi-permeable, self-adhesive catheter stabilizer was used as a catheter cover for all patients in Group 1 and Group 2. İ.V. After catheterization, "Information Form Regarding IV Catheter Application to Patient" was filled in for each participant.

Desefin and (active substance: ceftriaxone) biteral (active substance: ornidazole) and parol (active substance: paracetamol) as an analgesic were administered through the intravenous catheter inserted for the study. It was ensured that these drugs were sent in the form of infusion. Therefore, verbal consent was obtained from the participants to apply the catheter for the second time, except for the intravenous catheter attached, if the patient was to receive different intravenous therapy.

After the application, phlebitis development status was evaluated with the "Phlebitis Scale" published by the Infusion Nurses Association. As part of the follow-up of phlebitis, millimetric measurements were made with a transparent ruler and the degree of phlebitis was determined bu intestigator. The scale was applied every 8 hours for 72 hours by investigator.

Conditions

Phlebitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Klorheksidin

Deri antisepsisi, vasküler erişimden önce chlorhexidine kullanılarak yapılacaktır

Group Type: EXPERIMENTAL

%2 Klorheksidin

Intervention Type: OTHER

Effect on phlebitis

Alkol

Skin antisepsis will be performed using alcohol prior to vascular access

Group Type: EXPERIMENTAL

%2 Klorheksidin

Intervention Type: OTHER

Effect on phlebitis

Interventions

%2 Klorheksidin

Effect on phlebitis

Intervention Type: OTHER

Other Intervention Names

% 70 Alchol

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Alev Keskin

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Çukurova üniversitesi sağlık bilimleri fakültesi

Adana, Sarıçam, Turkey (Türkiye)

Çukurova university

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AKeskin

Identifier Type: -

Identifier Source: org_study_id