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IRCT20181105041563N6 IRCT 2020-12-06 Kermanshah University of Medical Sciences Evaluation the effect of hydrogel on pressure ulcer Evaluation the effect of hydrogel containing gentamicin on pressure ulcers 2020-11-21 anticipated 105 Complete https://irct.ir/trial/44945 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Qualified samples were entered into the study by convenience method and randomly divided into intervention groups (Hydrogel and Hydrogel containing gentamicin) and control. Blocks were done as follows: Hydrogel and Hydrogel containing gentamicin was assigned A and B codes respectively, and the control group received C code. The study blocks were ABC, ACB, BAC, BCA, CAB, CBA, BCC, CAB, CAB, and the ABC block was selected as the first block. Patients were assigned to Hydrogel and Hydrogel containing gentamicin, and control groups, respectively, and this method continued until the samples were completed. 2-3 Pressure ulcer. Intervention 1: First intervention group: in group 1, the wound will be dressed daily at 8:00 AM with hydrogel made by pharmacist researchers of Kermanshah University of Medical Sciences for 30 days, So that the hydrogel covers 2 mm from the wound surface and will be checked on the days of 1,3,7,14,21,30 by Push scale. Intervention 2: Second intervention group: in group 2, the wound will be dressed daily at 8:00 AM with hydrogel containing gentamicin made by pharmacist researchers of Kermanshah University of Medical Sciences for 30 days,So that the hydrogel containing gentamicin covers 2 mm from the wound surface and will be checked on the days of 1,3,7,14,21,30 by Push scale. Intervention 3: Control group: in group 3 the wound will be dressed every two days at 8:00 AM with 1/2 of the hydrocolloid sheet dressing made by Coloplast Denmark for 30 days, and will be checked on the days of 1,3,7,14,21,30 by Push scale. 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 specific program for publishing this project currently
public Somayeh Mahdavikian
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6715986479 +98 83 3816 2560 Somayeh.Mahdavikian@kums.ac.ir Kermanshah University of Medical Sciences scientific Somayeh Mahdavikian
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6715986479 +98 83 3816 2560 Somayeh.Mahdavikian@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Consent of the physician and the patient to participate in the study No addiction to drugs and alcohol, Insensitivity to hydrogels and gentamicin Absence of any signs of wound infection and skin disease Having aged over 18 years No diabetes, and kidney failure Stage 2 of The National Pressure Ulcer Advisory Panel (NPUAP) scale Lack of bleeding Earn points equal to 14-6 from Braden scale 18 years no limit Both Earn points more than 18 from Braden scale Administration of nitroglycerin and immunosuppressive drugs Occurrence of pressure ulcer in order to (The National Pressure Ulcer Advisory Panel (NPUAP) scale Need for any surgery Need for debridement Bleeding L89 Stage II decubitus ulcer Other Other Other First intervention group: in group 1, the wound will be dressed daily at 8:00 AM with hydrogel made by pharmacist researchers of Kermanshah University of Medical Sciences for 30 days, So that the hydrogel covers 2 mm from the wound surface and will be checked on the days of 1,3,7,14,21,30 by Push scale. Second intervention group: in group 2, the wound will be dressed daily at 8:00 AM with hydrogel containing gentamicin made by pharmacist researchers of Kermanshah University of Medical Sciences for 30 days,So that the hydrogel containing gentamicin covers 2 mm from the wound surface and will be checked on the days of 1,3,7,14,21,30 by Push scale. Control group: in group 3 the wound will be dressed every two days at 8:00 AM with 1/2 of the hydrocolloid sheet dressing made by Coloplast Denmark for 30 days, and will be checked on the days of 1,3,7,14,21,30 by Push scale. Healing of pressure ulcer. Timepoint: Day one, three, seven, fourteen, twenty one and thirty of the study. Method of measurement: Push scale. Kermanshah University of Medical Sciences Approved 2019-09-04 Ethics committee of Kermanshah University of Medical Sciences Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)