A Randomized Controlled clinical Trial comparing the efficacy of using Platelet-Rich Fibrin (PRF) with conventional technique of Cleft Palate Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patients under PRF treatment group show statistically significant improved wound healing in comparison with non PRF patients group .
研究概览
简要总结
The purpose of this study is to compare the effectiveness of using Platelet-Rich Fibrin (PRF) with conventional technique in cleft palate repair, by conducting a Randomized Controlled clinical Trial. We hope to learn whether using PRF can improve the healing of the surgical wound and ultimately reduce the occurrence of palatal fistula.
1.1 Source of Data: All cases of cleft palate in Department of plastic and reconstructive surgery at KLE’s Prabhakar Kore hospital, Belgaum**.**
1.2 Study Design: Randomized Controlled Trial
Primary Purpose : Treatment
Allocation : Randomized
Interventional model : Parallel assignment
Masking : Single
Test/PRF Study group Pt: patients treated with PRF post-surgery;
No intervention Control group Pc : patients not treated with PRF post-surgery.
Hypothesis 1: Patients under PRF treatment in Pt group show statistically significant improved wound healing in comparison with non PRF patients in group Pc .
Hypothesis 2: Number of patients in Pt developing palatal fistula is significantly less than the Number of patients in Pc developing palatal fistula.
Null hypothesis:
No statistically significant difference between the group Pt and group Pc, on the following parameters :
· Wound healing : complications and duration
Palatal fistula ( after 6 months ) : occurred / not occurred
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
- 1.00 Year(s) 至 3.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted for cleft palate repair under Department of Plastic & Reconstructive Surgery in KLE Prabhakar Kore hospital, Belgaum fulfilling the following criteria: 1 Patients with non-syndromic cleft palate.
- •2 Patient Age: 1 to 3 years 3 Consent signed for application of PRF and follow up examinations for 6 months post initial treatment.
排除标准
- •1 Lack of consent 2 Patients with syndromic cleft disease or bleeding disorders.
结局指标
主要结局
Patients under PRF treatment group show statistically significant improved wound healing in comparison with non PRF patients group .
时间窗: Wound healing status reviewed until discharge : 1 week. | Palatal Fistula and other issues reviewed : 3 and/or 6 months
次要结局
- Number of patients in PRF group developing palatal fistula is significantly less than the Number of patients without PRF developing palatal fistula(review conducted 6 months post discharge)
研究者
Dr Soujanya M
J. N. Medical College KLE Academy of Higher Education and Research Belgaum