The Effectiveness of Stingless Bee Honey (Kelulut Honey) Dressing Versus Conventional Gel Dressing for Wound Bed Preparation in Diabetic Patients With Cavity Wounds: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Size of granulation tissue
研究概览
简要总结
There has been no study yet on the effect of stingless bee honey (Kelulut honey) produced by Melipolini sp. in diabetic wound healing in Malaysia. Kelulut honey, apart from possessing similar pro-healing properties with other honey, is also found to have a better antioxidant capacity, anti-inflammatory, and free radical scavenging activity than Tualang honey. These effects are due to the much higher content of phenolic and flavonoid substances in Kelulut honey, the key bioactive factors promoting wound healing and preventing oxidative stress-related injury. Australian researchers have also recently discovered a novel source of the rare disaccharide trehalose in stingless bee's honey, which is highly anti-diabetic and antioxidating. This study aims to investigate the efficacy of honey against gel dressing for wound bed preparation among diabetic patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •Aged between 18-70 years old
- •Patient with full thickness cavity wound
- •Controlled diabetes mellitus (defined as: fasting blood glucose (FBG) < 10 mmol/L upon selection)
排除标准
- •Severely contaminated wound/infected
- •Patient with history of allergy to honey or stingless bee product
- •Patients who are immunocompromised or on chronic steroid use ( defined as use of steroid for more than 2 weeks)
- •Pregnancy
- •End stage renal failure (ESRF) patient
结局指标
主要结局
Size of granulation tissue
时间窗: 30 days
This will be calculated based on the surface area of granulation tissue traced and marked on the Opsite Flexigrid by indelible fine tip marker. The amount of small squares will calculated and this will represent the surface area. The change between baseline and at day 30 will be recorded as percentage.
Wound size reduction
时间窗: 30 days
This will be calculated based on the surface area of the whole wound traced and marked on the Opsite Flexigrid by indelible fine tip marker. The amount of small squares will calculated and this will represent the surface area. The change between baseline and at day 30 will be recorded as percentage.
次要结局
未报告次要终点
研究者
Mohamad Aizat Bin Rosli
Principal Investigator
Universiti Sains Malaysia