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IRCT20220630055329N1 IRCT 2023-04-19 Tehran University of Medical Sciences Effectiveness of topical application of zinc oxide 25% versus zinc oxide 25% plus breastmilk on diaper dermatitis Comparison of the Effectiveness of topical application of zinc oxide 25% versus zinc oxide 25% plus breastmilk on children under 1 year old with diaper dermatitis ; a randomised controlled trial 2023-02-20 anticipated 42 Complete https://irct.ir/trial/64565 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to control variables, stratified randomization method will be used. To create a random sequence, age above and below six months and the type of milk as consumption or non-consumption of supplemental milk are considered, and thus four lists include 1- children under six months who drink supplemental milk, 2- children under six months who don't drink supplemental milk, 3- those over 6 months old who drink supplemental milk and 4- those over 6 months old who do not drink supplemental milk will be considered. Then, using random numbers software to determine the order of treatment (topical valve+ zinc oxide and zinc oxide alone) from 2 blocks A and B (instead of each of the treatments and in the form of A B and B) will be used. The study groups are: Group One: Topical Milk+ Zinc Oxide and Group Two: Zinc Oxide alone. Also, randomization tools, random sequence software (Random Allocation Software, Version 2.0) will be accessible from the address. https://random-allocation-software.informer.com/2.0, Blinding description: The present study is one blind, in which the researcher and analyzer of the data will be blind and the patient will not be blind. For this purpose, the type of treatment will be given to the interface based on the blocks made in the sealed envelopes. In order to hide random allocation, non -loose -end envelopes will be used with random sequences. Each of the random sequences created is recorded on a card and the cards are placed in the envelope of the letter respectively. In order to maintain random sequences, the outer surface of the envelopes is done in the same way. Finally, the envelopes will be sealed and placed in a box respectively. At the beginning of the registration of participants, one of the envelopes is opened by the trained person, and the assigned group of the participant is determined. The patient will be aware of the type of treatment, but the researcher and the analyzer will be blind. 3 Diaper dermatitis. Intervention 1: Intervention group: after determining the type of treatment, how to use breast milk or zinc will be explained to the child's caregiver in a ten-minute session by a trained mediator, and learning it (through an oral test) It will be ensured by the caregiver and an educational video will be sent to him. Due to the sensitive age of the participants in the study and the annoying and painful nature of this disease, and the uncertainty of breast milk treatment for diaper dermatitis, an approved treatment (25% zinc oxide) will be used in the intervention group besides breast milk, and the intervention group will be treated with local breast milk every 12 hours along with 25% zinc oxide from Caspian Pharmaceutical Company, every 12 hours. Caspian's zinc oxide contains 25 grams of zinc oxide per 100 grams, and during the treatment, approximately two tubes of it will be used for 14 times overally .It will also be recommended that the breast milk consumed be freshly expressed and not exposed to cold or other pollutants, and be applied on the baby's skin with a sterile applicator prepared by the research team, and about 3 cc of breast milk will be enough for each use (14 times in total). The treatment method adopted in Each person will continue for 7 days and in the entire affected area, and the child's parents/guardian will be asked not to use any other topical medicine during the study, and also wash the child only with warm water after each urination or defecation, dry it with air flow and change his diaper, and at the appointed time, use breast milk or ointment , and after it dries, diaper the child. In the future, the condition of the disease will be evaluated in each patient on a daily basis through available photo sending softwares, and any improvement or aggravation of the lesions will be recorded. Intervention 2: Control group: In this study, we compare the effect of breast milk combined with zinc oxide, against the use of zinc oxide alone. After determining the type of treatment, the method of using zinc will be explained to the child's caregiver practically in a ten-minute session by a trained mediator, and its learning (through an oral test) will be ensured by the caregiver. An educational video will also be sent to him. Patients in the control group will be treated with zinc oxide 25% by Caspin Pharmaceutical Company, every 12 hours. Zinc oxide by Caspin Company contains 25 grams of zinc oxide per 100 grams and during the treatment (for a total of 14 uses) approximately Two tubes will be used. The treatment method adopted in each person will continue for 7 days and in the entire area involved in diaper rash, and the parents/guardian of the child will be asked not to use any other topical medicine during the study, and also Wash the child with warm water after each urination or defecation (and before each drug application) ,let it dry with air flow and change his diaper and use breast milk or ointment before putting on diapers at the appointed time. The condition of the disease will be evaluated on a daily basis through available photo sending Apps and any recovery or aggravation of the lesion will be recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The study is not finished yet
public Dr alireza shafiee esfidvajani
Damavand st kiaee st bahrami hospital
Tehran Iran (Islamic Republic of) 1765777865 +98 21 3660 8312 Aghaeipardis@yahoo.com Tehran University of Medical Sciences scientific Alireza shafiee esfidvajani
Damavand st
Tehran Iran (Islamic Republic of) ١٧٦٥٧٧٧٨٦٥ +98 21 3660 8312 Aghaeipardis@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Infants under 1 no limit 1 year Both previous topical treatments systemic conditions L22 Diaper dermatitis Treatment - Drugs Treatment - Drugs Intervention group: after determining the type of treatment, how to use breast milk or zinc will be explained to the child's caregiver in a ten-minute session by a trained mediator, and learning it (through an oral test) It will be ensured by the caregiver and an educational video will be sent to him. Due to the sensitive age of the participants in the study and the annoying and painful nature of this disease, and the uncertainty of breast milk treatment for diaper dermatitis, an approved treatment (25% zinc oxide) will be used in the intervention group besides breast milk, and the intervention group will be treated with local breast milk every 12 hours along with 25% zinc oxide from Caspian Pharmaceutical Company, every 12 hours. Caspian's zinc oxide contains 25 grams of zinc oxide per 100 grams, and during the treatment, approximately two tubes of it will be used for 14 times overally .It will also be recommended that the breast milk consumed be freshly expressed and not exposed to cold or other pollutants, and be applied on the baby's skin with a sterile applicator prepared by the research team, and about 3 cc of breast milk will be enough for each use (14 times in total). The treatment method adopted in Each person will continue for 7 days and in the entire affected area, and the child's parents/guardian will be asked not to use any other topical medicine during the study, and also wash the child only with warm water after each urination or defecation, dry it with air flow and change his diaper, and at the appointed time, use breast milk or ointment , and after it dries, diaper the child. In the future, the condition of the disease will be evaluated in each patient on a daily basis through available photo sending softwares, and any improvement or aggravation of the lesions will be recorded. Control group: In this study, we compare the effect of breast milk combined with zinc oxide, against the use of zinc oxide alone. After determining the type of treatment, the method of using zinc will be explained to the child's caregiver practically in a ten-minute session by a trained mediator, and its learning (through an oral test) will be ensured by the caregiver. An educational video will also be sent to him. Patients in the control group will be treated with zinc oxide 25% by Caspin Pharmaceutical Company, every 12 hours. Zinc oxide by Caspin Company contains 25 grams of zinc oxide per 100 grams and during the treatment (for a total of 14 uses) approximately Two tubes will be used. The treatment method adopted in each person will continue for 7 days and in the entire area involved in diaper rash, and the parents/guardian of the child will be asked not to use any other topical medicine during the study, and also Wash the child with warm water after each urination or defecation (and before each drug application) ,let it dry with air flow and change his diaper and use breast milk or ointment before putting on diapers at the appointed time. The condition of the disease will be evaluated on a daily basis through available photo sending Apps and any recovery or aggravation of the lesion will be recorded. Zinc oxide application. Timepoint: Before intervention, one week after intervention. Method of measurement: Buckley scale. Tehran University of Medical Sciences Approved 2022-08-31 Ethics committee of Tehran university of medical sciences Ethics committiee , first floor , faculty of medicine , building no.1 , northern door , poorsina st. , ghods st. , enghelab st. Tehran Tehran Iran (Islamic Republic of)