Randomised Interventional study to evaluate the effectiveness of autologous PRP injection versus conventional Povidone Iodine dressing in the treatment of single acute post traumatic skin wound healing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To compare the mean reduction in size of wound area(%) after treatment with PRP injection versus Povidone Iodine dressing in patients with acute post traumatic skin wound.
研究概览
简要总结
Subjects admitted in Plastic surgery ward for the treatment of single acute post traumatic wound (otherwise healthy without co morbidities) are selected after wound debridement with consent from both the subjects and treating surgeon as per the inclusion and exclusion criteria. Study group(with PRP injection) /control group (povidone dressing) assigned as mentioned under randomization and allocation concealment method. Initial Ulcer area is recorded on day 0. Study subjects receive PRP Injection which is prepared by the PI and infiltrated in wound by the treating surgeon followed by non adhesive dressing done. Control subjects receive routine conventional povidone iodine dressing. Both these procedures done twice weekly. At the end of every week , size of wound area is noted as per treating surgeon advise. PUSH score of healing also recorded simultaneously. The initial wound area is considered as 100%. Thus the mean reduction in size of wound (area in %) at the end of every week is noted till discharge of both study and control subjects.
Mean duration of hospital stay is calculated for both study and control subjects.
Thus by comparing the rate of healing (% reduction in wound size) during the first/second week by two different method of treatment helps to rejuvenate further upcoming treatment.
Platelet Rich Plasma (PRP) preparation: PRP is prepared only after treating surgeon consent by receiving 8.5 ml whole blood of study subject in Acid citrate vial. The procedure is done under specific standard operating procedure followed at Mahatma Gandhi hospital Blood Centre as per NABH standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy subjects with accepted size of traumatic wound between 5-100sq.cm, admitted in ward for acute post traumatic wound management.
排除标准
- •Severe Anemic subjects, With low platelet count, With other co morbid illness, With H/o any chronic drug intake, with uncontrolled diabetes/pregnant and lactating women.
结局指标
主要结局
To compare the mean reduction in size of wound area(%) after treatment with PRP injection versus Povidone Iodine dressing in patients with acute post traumatic skin wound.
时间窗: The primary outcome i.e Reduction in size of wound(area) is assessed at the end of 1st week, 2nd week and on the day of discharge.
次要结局
- To observe the mean duration of hospital stay(in days)for subjects on treatment with PRP injection verses povidone Iodine dressing for acute post traumatic wound healing.(On the day of discharge.)
研究者
Dr Riya Achuthan Unny
S N Medical College, Jodhpur. Rajasthan.
