Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- incidence of pressure injuries
研究概览
简要总结
The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients.
Does applying this natural gel reduce the incidence of pressure injuries compared to standard care?
participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients aged 18 years or older.
- •Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.
- •Unconsciousness, being under sedation or assisted ventilation.
- •Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13-
- •No Diarrhea, serum Albumin level below 3.5 g/dl, no edema.
- •No limit of changes in body position with multiple injuries.
- •Family consent to participate in the study.
- •The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease.
- •All patients receiving standardized care (repositioning and pressure-relieving mattress).
排除标准
- •Family's unwillingness for the patient to continue participation
- •Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min.
- •Spinal cord injury cases
- •death or patient transmission in less than 48 hrs. after admission to the ICU.
研究组 & 干预措施
experimental group
Patients in this group will receive a topical application of the combined Aloe Vera-Peppermint gel on pressure-prone areas. The gel will be applied twice daily, in addition to the standard nursing care protocol for pressure injury prevention.
干预措施: combined Aloe Vera-Peppermint gel (Combination Product)
control group
Patients in this group will receive the standard nursing care protocol for pressure injury prevention as practiced in the ICU, which includes regular repositioning, skin assessment, cleansing, moisturizing, and use of pressure-relieving devices. No experimental Aloe Vera-Peppermint gel will be applied to this group.
结局指标
主要结局
incidence of pressure injuries
时间窗: From the date of ICU admission until 10 days
The number of participants who develop any new pressure injury during their ICU stay. Pressure injuries include Stage I, Stage II, Stage III, Stage IV, Unstageable, and Deep Tissue Pressure Injury, as defined by the National Pressure Injury Advisory Panel (NPIAP). Assessment will be performed daily by trained nursing staff using the Braden Scale and comprehensive clinical skin examination of pressure-prone areas.
次要结局
未报告次要终点
研究者
Ali Abd-Alredha Hussein
ph. D student
University of Baghdad