Evaluation of the Role of the Plasma-rich Growth Factor (PRGF) with Primary Cleft Palate Repair Versus Primary Cleft Palate Repair in Post-operative Wound Healing and Oronasal Fistula Occurrence, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- wound healing assesment (edema at 5th day post operatively)
研究概览
简要总结
Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?
详细描述
The primary objective is to assess and evaluate the improvement of wound healing (edema at 5th day post operatively) as a primary outcome, and secondary objective is to assess and evaluate the wound closure and the decreasing of the occurrence of the oronasal fistula as a secondary outcome among children with cleft palate, using plasma rich growth factor between nasal mucosa and palatal mucosa
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
- Single (Participant)
盲法说明
Single blinded study. Blinding to the patient will be ensured by masking the instruments during the follow up. The patient will be informed of the steps of the follow up (as mentioned in the consent form) without getting into details of the method of follow up.
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy patients (American Society of Anesthesiologists -ASA I and II); not older than 6-18 months
- •Patients with primary non-syndromic isolated cleft palate
- •Apprehensive to be in the study.
排除标准
- •Patients with recurrent palatal fistula
- •Existence of syndromic cleft palate
- •Blood diseases and platelet disorders (hematological disease)
- •Systematic disease radiotherapy or chemotherapy for malignancy
研究组 & 干预措施
plasma rich growth factor (PRGF) (intervention or study group)
plasma rich growth factor (PRGF) intervention or study group Has Surgical procedures "von Langenbeck technique " to repair cleft palate and placing plasma rich growth factors between nasal and palatal tissue then primary closure intraoperatively, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative
干预措施: Plasma Rich in Growth Factors (PRGF) (Other)
placebo (control group)
placebo (control group) Has Surgical procedures "von Langenbeck technique " to repair cleft palate primary closure, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative
干预措施: Placebo (Other)
结局指标
主要结局
wound healing assesment (edema at 5th day post operatively)
时间窗: first day after surgery, 3rd day, and 5th day
clinical records, percentage of persistence of edema number of participants with percentage of persisting of edema
次要结局
- wound healing assesment(2 years)
- the occurrence of oronasal fistula(first day after surgery to end of treatment at 3 months)
研究者
Sarah Samir Horia
assistant lecturer
Cairo University