Fingertip Amputation, Lalonde Protocol, Non-contact Low Frequency Ultrasound
Conditions
Keywords
non-contact low frequency ultrasound, Lalonde protocol, fingertip amputation
Brief 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.
Detailed 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 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.
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.
Sponsors
St. Luke's Hospital, Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Dimensions (mm2) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semmes Weinstein (Monofilament Sensitivity Test) | Assessed weekly. From randomization through study completion (an average of 8 weeks) | A monofilament will be used to determine sensory status in the affected finger. Patients report yes or no when asked if they can sense the monofilament. |
| Grip Strength (lbs) | Assessed weekly. From randomization through study completion (an average of 8 weeks) | A handgrip dynamometer will be used to determine the handgrip strength for patients in lbs. Larger numbers indicate increased strength. |
| Subjective Pain (Visual Analog Scale) | Assessed weekly. From randomization through study completion (an average of 8 weeks) | The Visual Analog Scale, or VAS, will be used to measure subjective pain. Patients will report subjective pain on a scale of 1-10 with 10 indicating worse pain. |
| Number of Visits (n) | From randomization through study completion (an average of 8 weeks) | The number of visits the patient attends will be recorded. It is expected that patient enrollment in the study will be complete by 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) | The Quick Disabilities of Arm, Shoulder, Hand (QuickDASH), a validating instrument, will be used to assess patient functional status. Scores range from 0-100. Higher scores indicate worse functional status. |
| Pinch Strength (lbs) | Assessed weekly. From randomization through study completion (an average of 8 weeks) | A pinch dynamometer will be used to determine the pinch strength for patients in lbs. Larger numbers indicate increased strength. |
| 2 point discrimination (mm) | Assessed weekly. From randomization through study completion (an average of 8 weeks) | Calipers will be used to determine patient 2-point discrimination status. A healthy patient is able to report discrimination between two points at 2-8mm at the fingertips. Larger values indicate worsening discrimination between two points and indicate worsening neurologic status. |
Countries
United States
Contacts
Primary ContactKristofer Matullo, MD
Backup ContactDouglas Lundy, MD
Outcome results
None listed