Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study
St. Luke's Hospital, Pennsylvania
Summary
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.
Description
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 aestheti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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). Exclusion Criteria: * 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
Interventions
- DeviceNon-contact Low Frequency Ultrasound
NCLF-US therapy involves delivering low-frequency (40 kHz), low-intensity (0.1-0.8 W/cm2) ultrasound energy via sterile water mist.
- OtherLalonde Protocol (standard of care)
Standard of care local wound therapy using the Lalonde protocol - rinsing the site with clean water, applying a grease layer, wrapping with a one-inch gauze wrap, and securing with Coban tape.
Location
- St. Luke's University Health NetworkBethlehem, Pennsylvania