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

NCT04683887 | Completed Results

• 1 other identifier: TapeK_Gesso_ABM_PSO
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema Arm; Fracture; Wrist

Keywords

tape; forearm cast

Outcome Measures

Primary Outcomes (2)

• Thumb Circumference

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

  baseline and 1 week

• Circumference of the Other 4 Fingers All Together

  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

  baseline and 1 week

Secondary Outcomes (3)

• Pain Degree by Numerical Rating Scale (NRS)

  1 week

• Number of Participants Taking Painkillers

  1 week

• Number of Participants With OED Entry

  1 week

Study Arms (2)

Tape application

EXPERIMENTAL

Device: Tape application

No tape application

NO INTERVENTION

Interventions

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

Tape application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

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

Piacenza, 29121, Italy

Location

Related Publications (2)

• 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.

  PMID: 34736885 BACKGROUND

• 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.

  PMID: 38261469 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Massimo Guasconi
• Organization: Azienda Unità Sanitaria Locale di Piacenza

m.guasconi2@ausl.pc.it

+39-0523-303853

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data processing will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSN

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: June 25, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: September 5, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)