A Comparative Study to Assess the Efficacy of Postoperative Dressing in the Prevention of Early Surgical Site Complication and Facilitation of Early Mobilization After Orthopaedic Surgeries on Hip and Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Incidence of Early Surgical Site Complications
研究概览
简要总结
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Objective:
The primary objective of this study is to evaluate and compare the efficacy of advanced wound dressings versus traditional gauze-based dressings in post-operative orthopedic care. The study aims to assess various parameters including patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
详细描述
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Brief Summary:
This study aims to compare the efficacy of advanced wound dressings with traditional gauze-based dressings in post-operative orthopedic care. The study evaluates patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Study Type: Interventional (Clinical Trial)
Study Design: Randomized Controlled Single-Centre Open-Label Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
his study is an open-label trial, meaning that there is no masking. All parties involved in the study, including participants, care providers, investigators, and outcome assessors, are aware of the type of dressing each participant receives.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years Undergoing orthopedic surgical procedures, elective or trauma, with a surgical wound size of more than 5 cm Provided informed consent
排除标准
- •Open fractures Revision surgeries Established infections Ongoing pharmacological anticoagulation prophylaxis Predisposing skin conditions Known allergy or hypersensitivity to any of the constituents of the dressings Any associated systemic injury precluding early mobilization Unwillingness to participate
结局指标
主要结局
Incidence of Early Surgical Site Complications
时间窗: Day 3, Day 7, Day 14 post-surgery
The primary outcome measure will be the incidence of early surgical site complications, including blisters, skin margin infection, maceration, rashes, redness, swelling, and wound dehiscence. These complications will be assessed at three time points: day 3, day 7, and day 14 post-surgery.
次要结局
- Nurses' Ease of Application and Removal of Dressings(Day 3, Day 7, Day 14 post-surgery)
- Pain Levels During Dressing Changes(Day 3, Day 7, Day 14 post-surgery)
- Patient Satisfaction Levels(Day 14 post-surgery)
- Patient Comfort and Mobility(Day 3, Day 7, Day 14 post-surgery)
研究者
Nidhi Srivastava
Ortho Matron
Base Hospital Delhi Cantt