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NCT04817020
Effect of Skin Antisepsis on Phlebitis
NA trial testing %2 Klorheksidin in Phlebitis in 79 participants. Completed in 16 October 2021.
30 September 2020
Quick facts
| Lead sponsor | Cukurova University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 79 |
| Start date | 1 January 2020 |
| Primary completion | 30 September 2020 |
| Estimated completion | 16 October 2021 |
| Sites | 2 locations across Turkey (Türkiye) |
Drugs / interventions tested
- %2 Klorheksidin
Conditions studied
- Phlebitis — all drugs for Phlebitis →
Sponsor
Cukurova University
Who can join
Adults 18 to 65, any sex, with Phlebitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04817020
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04817020 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cukurova University
- Last refreshed: 30 April 2025
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