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

Edema Arm Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683887
• Other study ID #: TapeK_Gesso_ABM_PSO
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: April 2023
• Source: Azienda Unità Sanitaria Locale di Piacenza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Edema Arm
• Fracture; Wrist
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Italy	Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza	Piacenza

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale di Piacenza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thumb circumference	thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)	1 week
Primary	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	pain degree	pain degree at T1	1 week
Secondary	painkillers	taking painkillers in the 4 hours prior to T1	1 week
Secondary	OED entries	number of OED entries for "intolerance to plaster cast" between T0 and T1	1 week