Role of Autologous Platelet-Rich Plasma Solution in Wound Healing in Diabetic Patients Undergoing Elective Cesarean Delivery
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 主要终点
- changes in wound healing
研究概览
简要总结
this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections
详细描述
In this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to Minia University hospital. The patients will be randomly assigned into two groups. The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, two weeks, four weeks and eight week after the cesarean section.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy
排除标准
- •The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy
研究组 & 干预措施
Control group
50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital
study group
50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.
干预措施: PRP (Biological)
结局指标
主要结局
changes in wound healing
时间窗: one week post-operatively
REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis,discharge ,approximation of the wound edges. each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing
次要结局
- morbidly wound healing(4-8weeks)
研究者
Hany Hassan Kamel
principal investigator
Minia University