PhlebitisNCT04817020
Effect of Skin Antisepsis on Phlebitis
A study testing %2 Klorheksidin in people with Phlebitis, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Phlebitis
- What is being tested?
- %2 Klorheksidin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 16 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Çukurova üniversitesi sağlık bilimleri fakültesi
Adana, Sarıçam
Çukurova university
Adana
About this study
Official title: Effect of Skin Antisepsis on Phlebitis in Peripheral Intravenous Catheter
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.
Read more
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
Read the 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
- Being tested
- %2 Klorheksidin
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%2 KlorheksidinOther
Also called % 70 Alchol
Effect on phlebitis
| Study group | Role | What they receive |
|---|---|---|
| Klorheksidin | Experimental | Deri antisepsisi, vasküler erişimden önce chlorhexidine kullanılarak yapılacaktır Receives: Other: %2 Klorheksidin |
| Alkol | Experimental | Skin antisepsis will be performed using alcohol prior to vascular access Receives: Other: %2 Klorheksidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jan 2020
- Primary completion30 Sep 2020
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhlebitisStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomize,controlled double-blind clinical trials
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Keskin, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817020
- Sponsor's protocol ID
- AKeskin
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skin Antisepsis on Phlebitis in Peripheral Intravenous Catheter
- ClinicalTrials.gov ID
- NCT04817020
- Acronym / sponsor ID
- AKeskin
- Conditions
- Phlebitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomize,controlled double-blind clinical trials
| Arm | Type | Receives |
|---|---|---|
| Klorheksidin | Experimental | Other: %2 KlorheksidinDeri antisepsisi, vasküler erişimden önce chlorhexidine kullanılarak yapılacaktır |
| Alkol | Experimental | Other: %2 KlorheksidinSkin antisepsis will be performed using alcohol prior to vascular access |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between the ages of 18-65, Patients who accept the study,
Key exclusion criteria (2 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| %2 KlorheksidinAlso: % 70 AlcholEffect on phlebitis | Other | Alkol, Klorheksidin |
Primary outcome
Patient information form
Time frame: 5 minute
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.
Information Form Regarding the Application of the IV Catheter to the Patient
Time frame: 30 minute
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.
Phlebitis Scale
Time frame: 72 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing %2 Klorheksidin in people with Phlebitis, run by Cukurova University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient information form (time frame: 5 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.