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

Not Applicable

Completed

• Conditions: Edema Arm; Fracture; Wrist

• Registration Number: NCT04683887
• Lead Sponsor: Azienda Unità 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

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Study Start: 2021-06-25
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
pain degree	1 week	pain degree at T1
painkillers	1 week	taking painkillers in the 4 hours prior to T1
OED entries	1 week	number of OED entries for "intolerance to plaster cast" between T0 and T1

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