Comparative Evaluation of clinical outcome between 4-0 Polydioxanone and 4-0 vicryl suture for closure in Primary Cleft Palate Surgery
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Wound Dehiscence, Wound healing, Mucosal Scarring, Suppuration
研究概览
简要总结
â—Vicryl is an absorbable, synthetic suture which is a braided copolymer of glycolic and lactic acid that is surface treated with polyglactin 370 and calcium stearate and has received gamma radiation. This radiation alters the suture material’s molecular structure and enhances its absorption rate in vivo.
â—Polydioxanone (PDS) or poly-p-dioxanone is a slowly absorbable monofilament suture composed of the polyester, poly (p-dioxanone). This is a monofilament with greater strength than monofilament nylon and polypropylene, and with less tissue drag than the multifilament materials.
Aim: To Compare and evaluate wound healing using 4-0 PDS and 6-0 Vicryl in cleft palate surgery.
Null Hypothesis: There is no difference in surgical outcome between the suture materials after primary palatoplasty
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with primary cleft palate Non syndromic patients.
排除标准
- •Syndromic Patients Palatal Fistula Medically compromised patients.
结局指标
主要结局
Wound Dehiscence, Wound healing, Mucosal Scarring, Suppuration
时间窗: follow up 1 week, 1 month, 3 months, 6 months
次要结局
- Mucosal Scarring, Suppuration(follow up 1 week, 1 month, 3 months, 6 months)
研究者
Dr Shrishty Bhardwaj
Saveetha Dental College