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

Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Fracture
• Intervention / Treatment: Other: the biobased polyester cast; Other: the synthetic fiberglass cast

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the biobased polyester cast group; biobased polyester cast was applied	Other: the biobased polyester cast; long arm casting
Active Comparator: the synthetic fiberglass cast group; synthetic fiberglass cast was applied	Other: the synthetic fiberglass cast; long arm casting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of patients with fracture union	clinical outcome	one month after intervention
the number of complications	clinical outcome	one month after intervention
patient satisfaction questionnaire		one month after intervention

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Study Chair: Tsungyu Lan, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: casting; Pediatric upper limb fracture; Bioabased polyester; Synthetic cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 110245-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the study protocol could be shared
• IPD Sharing Time Frame: one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No