Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04817020 |
| Other study ID # |
AKeskin |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
October 16, 2021 |
Study information
| Verified date |
December 2019 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
