Clinical trial NCT06102603: Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children
Official title: Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Fracture
Keywords: Pediatric upper limb fracture
casting
Bioabased polyester
Synthetic cast
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the number of patients with fracture union
timeFrame: one month after intervention
measure: the number of complications
timeFrame: one month after intervention
measure: patient satisfaction questionnaire
timeFrame: one month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Tsungyu Lan
role: STUDY_CHAIR
References: