CTRI/2024/03/064005尚未招募2 期
Randomized control trial of short-contact topical vitamin A ointment on chronic non-healing wounds compared to standard dressings in a tertiary care center.
DRMonishaS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical improvement of ulcer as assessed by push tool 3.0.
研究概览
简要总结
- Need for Study:Chronic wounds pose significant challenges due to prolonged healing times, affecting patients’ quality of life and incurring substantial healthcare costs. Available treatments often have limited success, necessitating advanced wound care therapies. Vitamin A has shown promise in wound healing, but its direct application to wounds requires further investigation.
- This study aims to investigate the efficacy of topical vitamin A ointment on chronic non-healing wounds compared to standard dressings.
- Literature Review: Previous studies have indicated the potential benefits of topical vitamin A in promoting wound healing. Experimental studies in animals and observational trials in humans have demonstrated accelerated healing and increased granulation tissue formation with topical retinoids.
- Study Objectives:
- To observe the effect of topical vitamin A ointment on chronic non-healing wounds using the Pressure Ulcer Scale for Healing (PUSH) tool.
- To compare the changes in ulcer dimensions after daily dressings with topical vitamin A ointment versus standard dressings over a four-week period.
- Materials and Methods:
- Study Design: Randomized Controlled Trial
- Study Period: March 2024 to September 2025
- Sample Size: 50 patients with chronic non-healing ulcers
- Inclusion and Exclusion Criteria specified
- Stratified Random Sampling method used for patient selection
- Methodology:
- Single-blind RCT with patients randomized into two groups: one receiving topical vitamin A ointment and the other standard dressings.
- Dressing protocol involves daily application of vitamin A ointment followed by alternate day dressings for four weeks.
- Ulcer measurements and assessment conducted weekly.
- Conclusion:
- The study aims to provide evidence for the effectiveness of topical vitamin A ointment in promoting the healing of chronic non-healing wounds, potentially offering a cost-effective and beneficial treatment option
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Giving written informed consent 2.Patients with chronic non-healing ulcer 3.Size of ulcer more than 0.5x0.5 cm but less than 10x10 cm 4.Duration of wound more than 3 weeks.
排除标准
- •1.Age less than 19 years 2.Large wounds more than 11x11cm 3.Infective ulcers 4.Chronic liver disease 5.Chronic renal disease 6.Deranged lipid profile • Taking vitamin A supplements • Severe protein malnutrition • Pregnant and lactating women • Loss to follow-up.
结局指标
主要结局
Clinical improvement of ulcer as assessed by push tool 3.0.
时间窗: Weekly assessment for 4 weeks.
次要结局
- Decreased ulcer area & depth in study group when compared to control group.(Weekly assessment for 4 weeks.)
研究者
Monisha.S
Akash institute of medical sciences and research center
研究点 (1)
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