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

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ClinicalTrials.gov Identifier: NCT04683887
Recruitment Status : Not yet recruiting
First Posted : December 24, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Massimo Guasconi, Azienda Unità Sanitaria Locale di Piacenza

Study Description
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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.


Condition or disease Intervention/treatment Phase
Edema Arm Fracture; Wrist Device: Tape application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Data processing will be blinded
Primary Purpose: Treatment
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.
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Fractures

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. thumb circumference [ Time Frame: 1 week ]
    thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)

  2. remaining 4 finger circumference [ Time Frame: 1 week ]
    difference between T0 and T1 in the circumference of the remaining 4 fingers merged and measured at the first phalanx


Secondary Outcome Measures :
  1. pain degree [ Time Frame: 1 week ]
    pain degree at T1

  2. painkillers [ Time Frame: 1 week ]
    taking painkillers in the 4 hours prior to T1

  3. OED entries [ Time Frame: 1 week ]
    number of OED entries for "intolerance to plaster cast" between T0 and T1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683887


Contacts
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Contact: Massimo Guasconi, MSN +390523303854 m.guasconi2@ausl.pc.it

Sponsors and Collaborators
Azienda Unità Sanitaria Locale di Piacenza
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Massimo Guasconi, RN, MSN, Azienda Unità Sanitaria Locale di Piacenza
ClinicalTrials.gov Identifier: NCT04683887    
Other Study ID Numbers: TapeK_Gesso_ABM_PSO
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimo Guasconi, Azienda Unità Sanitaria Locale di Piacenza:
tape
forearm cast
Additional relevant MeSH terms:
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Edema
Fractures, Bone
Wounds and Injuries