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OpenTrials
Completed

NCT Number: NCT04683887

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

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.

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Key information

Conditions

Edema Arm Arm Injuries Fracture; Wrist Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Piacenza, 29121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tape application

Device

Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast

Primary outcomes

  1. Thumb Circumference

    Time frame: baseline and 1 week

    thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)

  2. Circumference of the Other 4 Fingers All Together

    Time frame: baseline and 1 week

    difference between T0 and T1 in the circumference of the other 4 fingers (index, middle, ring and pinky) all side by side, measured at the first phalanx

Secondary outcomes

  1. Pain Degree by Numerical Rating Scale (NRS)

    Time frame: 1 week

    pain degree by NRS at T1. The NRS is an 11-point scale used to assess pain intensity, ranging from 0 to 10. A score of 0 indicates no pain, while 10 represents the worst pain imaginable. The NRS is a simple and quick method for patients to self-report their pain level.

  2. Number of Participants Taking Painkillers

    Time frame: 1 week

    Number of Participants that have been taken painkillers in the 4 hours prior to T1

  3. Number of Participants With OED Entry

    Time frame: 1 week

    Number of Participants with at least one OED entry for "intolerance to plaster cast" between T0 and T1

Sponsors and collaborators

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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