Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Patient satisfaction associated with early and delayed surgical site bathing
研究概览
简要总结
This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.
Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.
详细描述
The study is a single center, non-inferiority, parallel group, randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.
Patients will have follow-up with data collection at two, six and 12 weeks post-operatively. The primary outcome measure will be patient satisfaction as measured by a Likert Scale. The Likert Scale as utilized will be a patient reported outcome measure consisting of one question allowing the subject to express their attitude towards a particular subject: "How satisfied are you with your surgical treatment" with possible answers consisting of: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", and "very unsatisfied". The secondary outcome measures will be development of an infection (subcategorized as either superficial or deep) and development of peri-incisional inflammation (eg. adhesive rash).
Primary Objective: The primary objective of the study is to compare patient satisfaction as measured using a Likert Scale associated with early and delayed surgical site bathing.
Secondary Objectives: The secondary objective is to compare the infection rate of orthopaedic surgical wounds between early and delayed bathing.
Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patient who are not pregnant
- •Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula)
- •Diagnosis of a fracture meeting indication for operative intervention
- •Any fracture not requiring a splint for post-operative management
- •Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring external fixation, and acute fracture surgery)
排除标准
- •Fractures associated with presumed infection
- •Patients with multiple fractures
- •Fractures in patients with underlying associated immune compromise
- •Fractures in patients with underlying peripheral vascular disease
- •Use of VAC
- •Surgery performed through previous surgical wound
- •Patient homeless
- •Fractures in patients with underlying diabetes mellitus
- •Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need for external fixation)
研究组 & 干预措施
Delayed Bathing
Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
干预措施: Time to bathing (delayed) (Other)
Early Bathing
Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
干预措施: Time to bathing (early) (Other)
结局指标
主要结局
Patient satisfaction associated with early and delayed surgical site bathing
时间窗: Weeks 2, 6 and 12 post surgery
The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be "Very Satisfied" and a score of 0 will be "Very Dissatisfied."
次要结局
- Infection rate of orthopaedic surgical wounds between early and delayed bathing(Weeks 12 post surgery)
研究者
William Ricci
Chief Orthopaedic Trauma Service
Hospital for Special Surgery, New York