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IRCT20220317054324N1 IRCT 2022-04-30 Mashhad University of Medical Sciences The effect of Mentha piperita dressing for the prevention of phlebitis and local colonization The effect of Mentha piperita gel dressing for the prevention of phlebitis and local colonization in patients undergoing hemodialysis with temporary central venous catheter 2022-05-22 anticipated 60 Complete https://irct.ir/trial/62828 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this randomized, controlled, double-blind parallel group trial, 60 patients are randomly divided into intervention and control groups. For simple random allocation, two sequences produced by the randomization site are used, one of which is for random allocation of patients with diabetes and the other is related to the allocation of other patients. in this way, After the available sampling, if the patient has diabetes, the allocation of these patients will be done by a random sequence of patients with diabetes to homogenize the distribution of these patients between the two groups. These two sequences will be placed separately in two different boxes. Each sequences inside the box will be numbered A and B in the sealed envelopes. Mentha piperita (peppermint) and chlorhexidine gels prepare in two similar tubes with the same color and smell and distinguishe from each other only with A and B. Only a pharmacist is aware of type of gels. patients and relatives are not aware of the type of gel, as well as outcome assessor, Blinding description: The naming of tubes to A and B will be carried out by the pharmacologist assistant in the laboratory of the Faculty of Iranian and complementary medicine of Mashhad University of Medical Sciences and only the pharmacologist is aware of the type of gel. Mentha piperita and chlorhexidine gels prepare in two similar tubes with the same color and smell and distinguishe from each other only with A and B. N/A Renal failure. Intervention 1: Intervention group: Mentha piperita extract gel will be used in the intervention group.The researcher will prepare this gel based on carbapol in the laboratory of the Faculty of Iranian and Complementary Medicine of Mashhad University of Medical Sciences under the supervision of a pharmacologist. Mentha piperita is purchased from centers approved by the Faculty of Iranian and Complementary Medicine. Mentha piperita is soaked in a ratio of one to three in hydroalcoholic solvent (30% water and 70% alcohol). After 48 hours, the liquid extract is filtered and the solvent is removed to finally obtain a solid plant extract. Standardization of mint extract is done and then this extract will be prepared in 10% gel base and packed in a tube. For 24 hours after catheter placement, the researcher will change the catheter dressing daily in the morning and then disinfect it with betadine and wash the betadine with normal saline from the wound and apply the gel within a radius of 2.5. After 12 hours, the dressing is opened and the area is impregnated with gel and the same dressing is placed on the site. The researcher, in coordination with the staff, will ensure the use of the gel by face-to-face control or telephone reminders.These dressings are impregnated with gel twice a day for a maximum of 14 days and the catheter site is examined daily with Iranian Nurses Association's Inflammatory Criterial. Intervention 2: Control group: In this group, 2% chlorhexidine gel is prepared and used. The use of the gel and the evaluation of the catheter entry site for phlebitis and local colonization will be performed in the same way as the intervention group. Yes - There is a plan to make this available What will be shared: After determining the results, the information will be provided to the Vice Chancellor of Mashhad University of Medical Sciences for implementation in affiliated hospitals and also transferred to the Ministry of Health. Also, some data will be published in scientific journals as the main results of the research within 6 months. When: 6 months after the results are published To whom: Researches who are researching in this field (complementary and Alternative Medicine) Conditions: Analysis of main variables Where to obtain: Researcher email How to obtain: The data will be provided to the applicants after 1 month. Comments:
public mohadeseh gholami jami ghaleh shiri
Floor 1, No 117, After of 1th crrosroads, Tabatabayee 22, Tabatabayee street, Askariyeh sq, Tollab District, Mashhad town, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9157697635 +98 51 3251 6989 gholamijm992@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Reza Mazlom
Faculty of Nursing & Midwifery, Ebne Sina Street, doctora Cross, Daneshgah Ave, Mashhad Town
Mashhad Iran (Islamic Republic of) 9137913199 00985138598019-207 Mazlomr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The Patient is undergoing hemodialysis due to acute or chronic renal failure The patient has a temporary central venous catheter that is inserted into subclavian or jugular vein Age between 18-60 years The Patient may be hospitalized in the ward for at least 3 days Lack of a known immune deficiency disease such as cancer, AIDS Do not take topical antibiotics and anti-inflammatory at catheter insertion site in a recent week No occurrence of phlebitis at the first change of dressing Lack of sensitivity to the gel in the forearm test 18 years 60 years Both Systemic and local infection at the catheter insertion site Do not use or can not use the gel for any reason (N17-N19) renal failure Prevention Prevention Intervention group: Mentha piperita extract gel will be used in the intervention group.The researcher will prepare this gel based on carbapol in the laboratory of the Faculty of Iranian and Complementary Medicine of Mashhad University of Medical Sciences under the supervision of a pharmacologist. Mentha piperita is purchased from centers approved by the Faculty of Iranian and Complementary Medicine. Mentha piperita is soaked in a ratio of one to three in hydroalcoholic solvent (30% water and 70% alcohol). After 48 hours, the liquid extract is filtered and the solvent is removed to finally obtain a solid plant extract. Standardization of mint extract is done and then this extract will be prepared in 10% gel base and packed in a tube. For 24 hours after catheter placement, the researcher will change the catheter dressing daily in the morning and then disinfect it with betadine and wash the betadine with normal saline from the wound and apply the gel within a radius of 2.5. After 12 hours, the dressing is opened and the area is impregnated with gel and the same dressing is placed on the site. The researcher, in coordination with the staff, will ensure the use of the gel by face-to-face control or telephone reminders.These dressings are impregnated with gel twice a day for a maximum of 14 days and the catheter site is examined daily with Iranian Nurses Association's Inflammatory Criterial. Control group: In this group, 2% chlorhexidine gel is prepared and used. The use of the gel and the evaluation of the catheter entry site for phlebitis and local colonization will be performed in the same way as the intervention group. Phlebitis. Timepoint: Before the start of the intervention, daily up to maximum 14 days after the intervention. Method of measurement: Iranian Nurses Association's Inflammatory Criteria. Local colonization at catheter insertion site. Timepoint: Once If there was signs of vascular inflammation (phlebitis) with score 2 or more. Method of measurement: Blood agar culture and sending samples to Microbiology Laboratory. Mashhad University of Medical Sciences Approved 2022-03-15 Research Ethics committee of School of Nursing & Midwifery Mashhad University of Medical Sciences Faculty of Nursing & Midwifery, Ebne Sina Street, doctora Cross, Daneshgah Ave, Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)