CTRI/2025/04/084152尚未招募不适用
A Prospective Randomized Controlled Trial Comparing Cosmesis And Wound Complications Of Pediatric Clean Surgical Wounds Closed With Steri-Strips Versus Subcuticular Suturing
Bharati Hospital And Research Centre Bharati Vidyapeeth Deemed to be University Pune1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年4月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Comparing cosmesis and wound complications of pediatric clean surgical wounds closed with Steri-Strip versus Subcuticular Sutures
研究概览
简要总结
Thestudy will be conducted in a Tertiary Care Centre in Pune. Patients fulfillingthe inclusion criteria and consenting for the study will be selected. They willbe blinded and divided into 2 groups (Steri-Strips versus Subcuticular Suturing).Their personal data and clinical details will be noted. The surgical woundwould be assessed subjectively by the patient/ parent/ guardian and objectivelyby the Plastic Surgeon using the POSAS 2.0 scale at regular intervals (POD-5, at 2 weeksand at 2 months post surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing clean surgeries.
排除标准
- •History of surgery previously at proposed site of surgery.
- •Known co-morbidities (Diabetes, Bronchial Asthma, Tuberculosis).
- •Patient having severe anemia.
- •Patient with bleeding/ clotting disorder.
- •Patient having cutaneous infection or dermatitis pre-operatively in close proximity to the proposed surgical site.
- •Patient on chemotherapy or steroid treatment for other concomitant condition.
- •Surgical wounds deemed unfit for Steri-Strip application by operating surgeon at the time of wound closure (Presence of infection, high tension wounds/ wounds difficult to approximate with fingers, wounds with exudate, wounds over highly mobile areas like joints).
结局指标
主要结局
Comparing cosmesis and wound complications of pediatric clean surgical wounds closed with Steri-Strip versus Subcuticular Sutures
时间窗: Post operative day 5 | 2 weeks post surgery | 2 months post surgery
次要结局
- To demonstrate significant cost reduction by using Steri-Strips instead of subcuticular sutures for closure of pediatric clean surgical wounds(Post operative day 5)
研究者
研究点 (1)
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