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IRCT20220723055528N1 IRCT 2024-03-03 Tabriz University of Medical Sciences Investigating the effect of ostrich oil on the healing rate of pressure ulcers in premature babies Investigating the effect of ostrich oil on the healing rate of pressure ulcers in premature babies: A randomized controlled clinical trial 2024-01-21 anticipated 60 Complete https://irct.ir/trial/64928 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the selection of babies will be conducted using convenience sampling method and based on inclusion criteria in the first stage. In the next step, included infants will be assigned to two groups of intervention (routine care + ostrich oil) and control (routine care) using the random block method of four and six. In this study, random block design will be used to ensure the balance of the number of participants who enter the intervention and control groups at consecutive time intervals. In this way, for example, intervention (ostrich oil) is randomly assigned to the first block and routine care to the second block, and again intervention (ostrich oil) to the third block and so on. To conceal the assignment of samples to the groups, the code of the groups is written on a sheet of paper and placed inside the opaque envelopes, numbered consecutively, and the assignment of the group code to the samples will be done by a person not involved in the study (department secretary). in such a way that after selecting the eligible sample, the department secretary randomly selects an envelope and according to the code written in it, the baby will be placed in one of the intervention or control groups, Blinding description: Due to the nature of the intervention and the difference in the consistency, color and appearance of the routine treatment (ointments) and the desired intervention (ostrich oil) and also due to the recording of the treatments in the cardex of the infants, it was not possible to blind the nurses and the researcher, and the blinding of the researcher's assistance (who will determine the healing scores) and the statistical consultant of the study (who will analyze the data), will be conducted in the stage of scoring the wound and analyzing the data. 3 Premature babies with a gestational age of 28 to 32 weeks hospitalized in the neonatal intensive care unit with pressure ulcers caused by medical procedures.. Intervention 1: Intervention group: After determining the pressure ulcer score based on PUSH tool and recording it in the data collection form and completing newborns' demographic characteristics questionnaire based on the medical record, the score obtained from the PUSH tool will be approved by the neonatologist. Then, the written order to start the treatment (routine ointments + ostrich oil) will be given by the neonatologist and recorded in the newborn cardex by the relevant nurse. Ointments and ostrich oil will be applied on the pressure ulcer of the babies at the prescribed times ( one in between in equal intervals of 4 or 6 hours). In this study, ostrich oil which prepared in the laboratory of Bani Teb Aria with license number of "0395-94-S" and health license of 1633 and exploitation license of 123/32436 will be used. This oil also has the Sib Salamat logo and is available in 90cc containers in reputable pharmacies across the country. This product is extracted from ostrich visceral environmental fat in a completely pure form and without additives and essential oils. Ostrich oil will be applied by trained nurses on the pressure ulcers of the babies in the amount of 0.5 to 1cc (depending on the size of the ulcer) at the intervals determined by the neonatologist, so that a layer of oil covers the entire surface of the ulcer. Before applying ointments or ostrich oil on the surface of the ulcer, to remove the previously used oil, the desired area will be washed with sterile cotton dipped in lukewarm sterile distilled water and dried. During the treatment period (10 days), the rate of ulcer healing will be checked and recorded every 24 hours using the PUSH tool by the researcher assistant who is an experienced nurse working in the morning shifts and is blinded to the assignment of the samples to the groups. Intervention 2: Control group: After determining the pressure ulcer score based on PUSH tool and recording it in the data collection form and completing newborns' demographic characteristics questionnaire based on the medical record, the score obtained from the PUSH tool will be approved by the neonatologist. Then, the written order to start the treatment (Unit routine ointments) which is usually given every 8 hours or 12 hours will be given by the neonatologist and recorded in the newborn cardex by the relevant nurse. To use the ordered ointments, according to the size of the wound, the sterile applicator will be smeared with 0.5 to1cc of the ointment and applied as a one layer on the surface of the ulcer at the prescribed times (according to Cardex). Before applying ointments on the surface of the ulcer, to remove the previously used oil, the desired area will be washed with sterile cotton dipped in lukewarm sterile distilled water and dried. During the treatment period (10 days), the rate of ulcer healing will be checked and recorded every 24 hours using the PUSH tool by the researcher assistant who is an experienced nurse working in the morning shifts and is blinded to the assignment of the samples to the groups. 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 There is no further information.
public Roya Saboohi Khamneh
Artesh St., Baghshamal intersection, Al-Zahra Hospital, NICU 1 department
Tabriz Iran (Islamic Republic of) ۵۱۳۸۶۶۵۷۹۳ +98 41 3553 9161 saboohi_r@yahoo.com Tabriz University of Medical Sciences scientific Roya Saboohi Khamneh
Artesh St., Baghshamal intersection, Al-Zahra Hospital, NICU 1 department
Tabriz Iran (Islamic Republic of) ۵۱۳۸۶۶۵۷۹۳ +98 41 3553 6506 saboohi_r@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Gestational age 28 to 32 weeks Hospitalization in one of the NICU departments 1, 2 of Al-Zahra Hospital The presence of a pressure ulcer that needs treatment (score at least 3 based on the PUSH tool) The written order of the attending physician to carry out the medication orders 1 day no limit Both 1. Presence of congenital/autoimmune skin problems such as lupus erythematosus or neonatal ichthyosis 2. Existence of skin sensitivities that cause skin irritation or ointment application, which is medically prohibited. 3. Babies admitted from other centers with previous skin irritations Treatment - Other Treatment - Other Intervention group: After determining the pressure ulcer score based on PUSH tool and recording it in the data collection form and completing newborns' demographic characteristics questionnaire based on the medical record, the score obtained from the PUSH tool will be approved by the neonatologist. Then, the written order to start the treatment (routine ointments + ostrich oil) will be given by the neonatologist and recorded in the newborn cardex by the relevant nurse. Ointments and ostrich oil will be applied on the pressure ulcer of the babies at the prescribed times ( one in between in equal intervals of 4 or 6 hours). In this study, ostrich oil which prepared in the laboratory of Bani Teb Aria with license number of "0395-94-S" and health license of 1633 and exploitation license of 123/32436 will be used. This oil also has the Sib Salamat logo and is available in 90cc containers in reputable pharmacies across the country. This product is extracted from ostrich visceral environmental fat in a completely pure form and without additives and essential oils. Ostrich oil will be applied by trained nurses on the pressure ulcers of the babies in the amount of 0.5 to 1cc (depending on the size of the ulcer) at the intervals determined by the neonatologist, so that a layer of oil covers the entire surface of the ulcer. Before applying ointments or ostrich oil on the surface of the ulcer, to remove the previously used oil, the desired area will be washed with sterile cotton dipped in lukewarm sterile distilled water and dried. During the treatment period (10 days), the rate of ulcer healing will be checked and recorded every 24 hours using the PUSH tool by the researcher assistant who is an experienced nurse working in the morning shifts and is blinded to the assignment of the samples to the groups. Control group: After determining the pressure ulcer score based on PUSH tool and recording it in the data collection form and completing newborns' demographic characteristics questionnaire based on the medical record, the score obtained from the PUSH tool will be approved by the neonatologist. Then, the written order to start the treatment (Unit routine ointments) which is usually given every 8 hours or 12 hours will be given by the neonatologist and recorded in the newborn cardex by the relevant nurse. To use the ordered ointments, according to the size of the wound, the sterile applicator will be smeared with 0.5 to1cc of the ointment and applied as a one layer on the surface of the ulcer at the prescribed times (according to Cardex). Before applying ointments on the surface of the ulcer, to remove the previously used oil, the desired area will be washed with sterile cotton dipped in lukewarm sterile distilled water and dried. During the treatment period (10 days), the rate of ulcer healing will be checked and recorded every 24 hours using the PUSH tool by the researcher assistant who is an experienced nurse working in the morning shifts and is blinded to the assignment of the samples to the groups. The time required for the healing of pressure ulcers in premature babies caused by medical procedures. Timepoint: Examining the rate of wound healing in two groups up to 7 days every 24 hours using the PUSH tool. Method of measurement: Using Pressure Ulcer Scale for Healing (PUSH). Tabriz University of Medical Sciences Approved 2023-02-07 Ethics committee of Tabriz University of Medical Sciences South Shariati St, Faculty of Nursing and Midwifery, Tabriz, Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)