Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.
- Conditions
- Edema ArmFracture; Wrist
- Registration Number
- NCT04683887
- Lead Sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Brief Summary
Wrist fractures are a very common event affecting patients of all ages and are estimated to account for approximately 10% -25% of all fractures. 70-90% of fractures are treated with closed reduction and forearm cast. In 2019, 17.4% of wrist fractured patients treated with a plaster cast at the Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza had a second access to the OED for edema, pain or "intolerance to the plaster cast ".
In literature, there are several studies that demonstrate the effectiveness of adhesive elastic tape for edema control, mostly lymphedema secondary to breast cancer or post-operative edema after knee arthroplasty, although a definitive evidence is still needed.
With this trial, the investigators aim to evaluate the tape effectiveness in counteracting hand edema formation in wrist fractured adult patients treated with forearm cast.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Patients with growth plates closed on radiographic examination
- Unilateral distal radius fracture associated or not with ulnar styloid fracture
- Wrist fracture requiring bloodless reduction and immobilization with a forearm cast
- Patients with multiple fractures
- Polytrauma patients
- Patients with previous plegia / paralysis of the fractured limb
- Patients with previous lymphedema of the fractured limb
- Patients with access to the OED during the night when the organization does not guarantee the presence of 2 nurses
- Wounds or abrasions in the area of application of the tape
- Acute thrombosis (upper limb veins)
- Scars not perfectly healed in the area of application of the tape
- Dermatitis, psoriatic manifestations or erythema in the area of application of the tape
- Known allergy to acrylic (patch glue)
- Solid neoplasms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Thumb Circumference baseline and 1 week thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Circumference of the Other 4 Fingers All Together baseline and 1 week difference between T0 and T1 in the circumference of the other 4 fingers (index, middle, ring and pinky) all side by side, measured at the first phalanx
- Secondary Outcome Measures
Name Time Method Number of Participants With OED Entry 1 week Number of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1
Pain Degree by Numerical Rating Scale (NRS) 1 week pain degree by NRS at T1. The NRS is an 11-point scale used to assess pain intensity, ranging from 0 to 10. A score of 0 indicates no pain, while 10 represents the worst pain imaginable. The NRS is a simple and quick method for patients to self-report their pain level.
Number of Participants Taking Painkillers 1 week Number of Participants that have been taken painkillers in the 4 hours prior to T1
Related Research Topics
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Trial Locations
- Locations (1)
Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
🇮🇹Piacenza, Italy
Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza🇮🇹Piacenza, Italy