Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.

Study Overview
=================
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.

Official Title
-----------------
Randomized and Controlled Prospective Study on Use of the Adhesive Elastic Tape to Control Hand Edema in Patients With a Wrist Fracture Treated With Forearm Plaster.

Conditions
-----------------
Edema Arm, Fracture; Wrist

Intervention / Treatment
-----------------
* Device: Tape application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tape application<br> | Device: Tape application<br>* Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast<br>|
| No Intervention: No tape application<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thumb circumference | thumb circumference difference between baseline (T0) and follow-up on day 7 (T1) | 1 week | 
| remaining 4 finger circumference | difference between T0 and T1 in the circumference of the remaining 4 fingers merged and measured at the first phalanx | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain degree | pain degree at T1 | 1 week | 
| painkillers | taking painkillers in the 4 hours prior to T1 | 1 week | 
| OED entries | number of OED entries for intolerance to plaster cast between T0 and T1 | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tape, forearm cast