Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Wound Dimensions (mm2)
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of non-contact low frequency ultrasound in populations sustaining fingertip amputations. The main question it aims to answer is:
• Does non-contact low frequency ultrasound significantly improve patient outcomes in patients sustaining acute fingertip amputations?
Researchers will compare non-contact low frequency ultrasound to a standard Lalonde protocol to answer this questions.
Participants will be randomized one of the two study arms and evaluated by wound care therapy. They will receive cohort appropriate therapy sessions 2-3 times per week with measurement of wound size once per week.
详细描述
Fingertip injuries rank among the most prevalent hand injuries, leading to nearly 5 million emergency department visits annually. Particularly common among adults, are lacerations, crush injuries, and avulsions affecting the thumb, index finger, and middle finger. As fingertip amputations encompass a diverse range of injuries involving soft tissue, bone, and/or nail, there is no singular recommended treatment as the standard of care. Instead, treatment is tailored to the individual patient, aiming to minimize pain, optimize healing, preserve sensory and motor function, and maintain an aesthetically acceptable appearance.
Possible treatment options for fingertip amputations without exposure of the distal phalanx include primary closure, healing by secondary intention, completion/revision amputation, full-thickness skin grafting, and split-thickness skin grafting, or flap coverage. However, when soft tissue allows, primary closure or healing by secondary intention have demonstrate positive and reliable outcomes.
New technologies, such as non-contact low-frequency ultrasound (NCLF-US), continue to be introduced to support healing of acute and chronic injuries to improve patient outcomes. While a moderate amount of research exists demonstrating safety and efficacy of NCLF-US in expediting the healing of chronic wounds, there is limited research on its efficacy in the treatment of acute injuries.
Given the significance of optimizing healing, especially in a population predominantly composed of young men engaged in manual labor, it is reasonable to wonder about the efficacy of NCLF-US in the treatment of fingertip amputations without exposed bone managed through secondary intention. This study aimed to compare the efficacy of NCLF-US in combination with standard treatment for secondary healing versus the standard treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
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
- •Individuals aged 18 years or older with an acute traumatic fingertip amputation without exposed bone or tendons (Allen 1, Tamai level 1; ICD-10 codes S68.5 and S68.6).
排除标准
- •Patients less than 18 years old,
- •Injuries involving exposed bone
- •Those with diagnosis of vascular disease
- •Individuals with clinical suspicion or diagnosis of infection
- •Unable to comply with prescribed therapy sessions
- •Patients undergoing primary closure or surgical intervention
- •Patients experiencing subsequent trauma following treatment initiation
结局指标
主要结局
Wound Dimensions (mm2)
时间窗: Assessed weekly. From date of randomization through study completion (an average of 8 weeks)
Would dimensions will be measured in two dimensions using a ruler and recorded.
Time to Healing (days)
时间窗: From randomization through study completion (an average of 8 weeks)
Time to healing will be determined in days from randomization through study completion. This will vary between groups, but is expected to be complete by 8 weeks for all patients.
次要结局
- Subjective Pain (Visual Analog Scale)(Assessed weekly. From randomization through study completion (an average of 8 weeks))
- 2 point discrimination (mm)(Assessed weekly. From randomization through study completion (an average of 8 weeks))
- Semmes Weinstein (Monofilament Sensitivity Test)(Assessed weekly. From randomization through study completion (an average of 8 weeks))
- Grip Strength (lbs)(Assessed weekly. From randomization through study completion (an average of 8 weeks))
- Pinch Strength (lbs)(Assessed weekly. From randomization through study completion (an average of 8 weeks))
- Number of Visits (n)(From randomization through study completion (an average of 8 weeks))
- Functional Scores (Quick Disabilities of Arm, Shoulder, Hand)(Assessed weekly. From randomization through study completion (an average of 8 weeks))