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

NCT ID: NCT04683887

Last Updated: 2025-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2023-03-23

Brief Summary

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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

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Conditions

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Edema Arm Fracture; Wrist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Data processing will be blinded

Study Groups

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Tape application

Group Type EXPERIMENTAL

Tape application

Intervention Type DEVICE

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

No tape application

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Unita Sanitaria Locale di Piacenza

OTHER

Sponsor Role lead

Responsible Party

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Massimo Guasconi

RN, MSN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Piacenza, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 34736885 (View on PubMed)

Guasconi M, Zilli Riboni D, Civardi A, Bolzoni M, Granata C, Beretta M, Genovese A, Mozzarelli F, Quattrini F, Maniscalco P. The use of adhesive elastic tape for hand oedema control in patients with a wrist fracture treated in a cast: A pilot study. Int J Orthop Trauma Nurs. 2024 May;53:101059. doi: 10.1016/j.ijotn.2023.101059. Epub 2023 Oct 22.

Reference Type DERIVED
PMID: 38261469 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TapeK_Gesso_ABM_PSO

Identifier Type: -

Identifier Source: org_study_id

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