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

Primary Purpose

Edema Arm, Fracture; Wrist

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tape application
Sponsored by
Azienda Unità Sanitaria Locale di Piacenza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edema Arm focused on measuring tape, forearm cast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tape application

No tape application

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2020
Last Updated
April 20, 2023
Sponsor
Azienda Unità Sanitaria Locale di Piacenza
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1. Study Identification

Unique Protocol Identification Number
NCT04683887
Brief Title
Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Unità Sanitaria Locale di Piacenza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema Arm, Fracture; Wrist
Keywords
tape, forearm cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Data processing will be blinded
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tape application
Arm Type
Experimental
Arm Title
No tape application
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Tape application
Intervention Description
Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
Primary Outcome Measure Information:
Title
thumb circumference
Description
thumb circumference difference between baseline (T0) and follow-up on day 7 (T1)
Time Frame
1 week
Title
remaining 4 finger circumference
Description
difference between T0 and T1 in the circumference of the remaining 4 fingers merged and measured at the first phalanx
Time Frame
1 week
Secondary Outcome Measure Information:
Title
pain degree
Description
pain degree at T1
Time Frame
1 week
Title
painkillers
Description
taking painkillers in the 4 hours prior to T1
Time Frame
1 week
Title
OED entries
Description
number of OED entries for "intolerance to plaster cast" between T0 and T1
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Orthopedic ER o Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34736885
Citation
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.
Results Reference
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Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.

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