Clinical trial NCT04683887: Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema Arm
Fracture; Wrist
Keywords: tape
forearm cast
Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: thumb circumference
timeFrame: 1 week
measure: remaining 4 finger circumference
timeFrame: 1 week
Secondary outcomes:
measure: pain degree
timeFrame: 1 week
measure: painkillers
timeFrame: 1 week
measure: OED entries
timeFrame: 1 week
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
Study officials:
References:
citation: Guasconi M, Riboni DZ, Granata C, Bolzoni M, Beretta M, Mozzarelli F, Maniscalco P. Randomised controlled prospective study of the use of adhesive elastic tape for the control of hand oedema in patients with a wrist fracture treated in a cast: a study protocol. Int J Orthop Trauma Nurs. 2022 Feb;44:100881. doi: 10.1016/j.ijotn.2021.100881. Epub 2021 Jun 19.