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

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.

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.

Study Overview

• Status: Completed
• Conditions: Edema Arm; Fracture; Wrist
• Intervention / Treatment: Device: Tape application

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Massimo Guasconi, MSN; Phone Number: +390523303854; Email: m.guasconi2@ausl.pc.it

Study Locations

• Italy
  • Piacenza, Italy, 29121
    • Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale di Piacenza

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: tape; forearm cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Edema
• Other Study ID Numbers: TapeK_Gesso_ABM_PSO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No