Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Wound healing
研究概览
简要总结
randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.
详细描述
In this study the subject will be randomized using electronic randomization 1:1 ratio. The randomization list was generated electronically through R using the Random Allocation Rule. The data will be collected using Assessment sheet of patient with second stage pressure ulcer tool. Patients will equally be allocated into 2 groups randomly. The zinc oxide group will receive topical zinc oxide twice every 12 hours daily and patients in the MEBO group will receive topical MEBO ointment twice every 12 daily. Patient will be examined daily till complete healing for the pressure ulcer and maximum one month. The Bates-Jensen Wound Assessment Tool (BWAT) will be used to evaluate wound healing. It is a validated wound assessment tool which is used in many healthcare settings for wound assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking in this study
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
- •Willing to participate.
- •KAMC cases in medical ward, neuroscience ward, and intensive care unit.
- •Newly cases diagnosed with second stage pressure ulcer according to the European pressure ulcer advisory panel/national pressure ulcer advisory panel (NPUAP) guidelines.
排除标准
- •Not consenting to participate
- •Patients with suspected hypersensitivity reactions to any of the topical formulation's ingredients.
- •Either a category III or IV pressure ulcer.
- •Evidence of deep tissue injury (exudative drainage, purple or maroon localized area of discolored intact skin or blood-filled blister due to pressure damage).
- •Signs of wound infection (pus draining from the ulcer, a foul-smelling odour, tenderness, heat and increased redness in the surrounding skin and fever).
- •Patients who undertaking other therapies that could affect healing, such as corticosteroids, radiation therapy, or chemotherapy for cancer.
- •Heavy smoking (more than 20 cigarettes a day).
- •Concomitant chronic disease (e.g., diabetes mellitus or frank vascular disease such as Buerger's disease).
- •Patients who unable to continue the study because of death, discharge, or change in the care setting.
研究组 & 干预措施
The zinc oxide group
The zinc oxide group will receive topical zinc oxide twice every 12 hours daily
干预措施: zinc oxide (Drug)
MEBO group
patients in the MEBO group will receive topical MEBO ointment twice every 12 daily
干预措施: MEBO Wound Ointment (Drug)
结局指标
主要结局
Wound healing
时间窗: 30 days
Wound healing will be assessed by using Bates-Jensen Wound Assessment Tool (BWAT) daily for both treatments. (BWAT) consists of 13 items to evaluate wound size, type and depth, Each item is graded on a scale of 1 to 5, where a score of 1 indicates progress toward healing while a score of 5 indicates the absence of healing or wound deterioration. Cumulative BWAT scores vary from 13 to 65
次要结局
- Recovery time(30 days)