Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2022-09-28

Brief Summary

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From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.

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Detailed Description

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The clinical trial was approved by the research ethics review committee of the author's hospital and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) \[9\] diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.

Conditions

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Upper Limb Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The clinical trial was approved by the research ethics review committee of the author's hospital (Number XXX) and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I9 supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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the biobased polyester cast group

biobased polyester cast was applied

Group Type EXPERIMENTAL

the biobased polyester cast

Intervention Type OTHER

long arm casting

the synthetic fiberglass cast group

synthetic fiberglass cast was applied

Group Type ACTIVE_COMPARATOR

the synthetic fiberglass cast

Intervention Type OTHER

long arm casting

Interventions

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the biobased polyester cast

long arm casting

Intervention Type OTHER

the synthetic fiberglass cast

long arm casting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital

Exclusion Criteria

* displaced or unstable fractures indicated for close or open reduction and fixation
* previous surgeries to the affected upper limb
* history of any chronic skin pathology (e.g., atopic dermatitis)
* known allergy to cast materials

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No