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IRCT20181105041563N1 IRCT 2018-12-05 Vice chancellor for research, Kermanshah University of Medical Sciences Comparative of the effect of Aloe Vera Gel and Sildenafil ointment on Pressure ulcers in stage II Comparative evaluation of the effect of Aloe Vera Gel and Sildenafil ointment on Pressure ulcers in stage II 2017-12-22 anticipated 120 Complete https://irct.ir/trial/35480 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (Aloe Vera Gel, sildenafil Ointment and Combination of Aloe Vera Gel and Sildenafil Ointment) and control. Blocks were done as follows: To dressing groups with Aloe Vera Gel, sildenafil Ointment and Combination of Aloe Vera Gel and Sildenafil Ointment was assigned A ، B and C codes respectively, and the control group received D code. The study blocks were ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, and the ABCD block was selected as the first block. Patients were assigned to Aloe Vera Gel, sildenafil Ointment ,Combination of Aloe Vera Gel and Sildenafil Ointment , and control groups, respectively, and this method continued until the samples were completed. 2-3 pressure ulcer. Intervention 1: Intervention group: In group 1, the wound will be dressed daily at 8:00 AM with Aloe Vera gel (94%) for 30 days, and will be checked on the days of 1,3,7,14,21,30 by push scale. The brand of this product is Aloe Vera gel and its scientific name Aloe barbadensis Miller. This herb is used as a gel and has antimicrobial and antioxidant effects, increased moisture, anti-inflammatory effects, inhibited thromboxane (an ulcer healing inhibitor), and increased blood flow to the wound site. Intervention 2: In group 2, the ulcer will be dressed with sildenafil citrate (. 3%) ointment for 8 days, and will be dressed for 30 days, and will be checked in push-scale on days 1,3,7,14,21,30.The brands of this ointment are Viagra and Revatio. It has nitric oxide compounds, which have been shown to be effective in wound healing. These compounds stimulate cell proliferation, stimulate the activity of fibroblasts, collagen release, antimicrobial effect, antifungal, angiogenesis, increased blood flow to the site of injury and increase the secretion of the growth factor. Intervention 3: In group 3, the ulcer, at 8 o'clock in the morning, with a combination of sildenafil citrate ointment(. 3%) and Aloe Vera gel (94%) will be dressed in a 3: 2 ratio for 30 days and will be examined by push-scale on days 1,3,7,14,21,30. Intervention 4: Control group: In group 4, the ulcer, up to 30 days, every two days, at 8 o'clock, will be dressed with Hydrocolloid(Comfeel) and will be checked by push-scale on 1,3,7,14,21,30 days. 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 School of Nursing and Midwifery 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 School of Nursing and Midwifery Iran (Islamic Republic of) Consent of the physician and the patient to participate in the study Insensitivity to Aloe vera and sildenafil The absence of any signs of wound infection skin disease, having aged over 18 years stage 2 of Starling scale Lack of bleeding earn points equal to 14-6 from Braden scale no addiction to drugs and alcohol no diabetes, and kidney failure 18 years no limit Both Reduction of platelets and hemoglobin need for debridement reluctance to continue cooperation need for any surgery bleeding death L89.1 Stage II decubitus ulcer Other Other Other Other Intervention group: In group 1, the wound will be dressed daily at 8:00 AM with Aloe Vera gel (94%) for 30 days, and will be checked on the days of 1,3,7,14,21,30 by push scale. The brand of this product is Aloe Vera gel and its scientific name Aloe barbadensis Miller. This herb is used as a gel and has antimicrobial and antioxidant effects, increased moisture, anti-inflammatory effects, inhibited thromboxane (an ulcer healing inhibitor), and increased blood flow to the wound site. In group 2, the ulcer will be dressed with sildenafil citrate (. 3%) ointment for 8 days, and will be dressed for 30 days, and will be checked in push-scale on days 1,3,7,14,21,30.The brands of this ointment are Viagra and Revatio. It has nitric oxide compounds, which have been shown to be effective in wound healing. These compounds stimulate cell proliferation, stimulate the activity of fibroblasts, collagen release, antimicrobial effect, antifungal, angiogenesis, increased blood flow to the site of injury and increase the secretion of the growth factor. In group 3, the ulcer, at 8 o'clock in the morning, with a combination of sildenafil citrate ointment(. 3%) and Aloe Vera gel (94%) will be dressed in a 3: 2 ratio for 30 days and will be examined by push-scale on days 1,3,7,14,21,30. Control group: In group 4, the ulcer, up to 30 days, every two days, at 8 o'clock, will be dressed with Hydrocolloid(Comfeel) and will be checked by push-scale on 1,3,7,14,21,30 days Healing of pressure ulcer. Timepoint: Day one, three, seven, fourteen, twenty one and thirty of the study. Method of measurement: push scale. Vice chancellor for research, Kermanshah University of Medical Sciences Approved 2017-06-14 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)