Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- patient satisfaction questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
the biobased polyester cast group
biobased polyester cast was applied
Intervention: the biobased polyester cast (Other)
the synthetic fiberglass cast group
synthetic fiberglass cast was applied
Intervention: the synthetic fiberglass cast (Other)
Outcomes
Primary Outcomes
patient satisfaction questionnaire
Time Frame: one month after intervention
the number of patients with fracture union
Time Frame: one month after intervention
clinical outcome
the number of complications
Time Frame: one month after intervention
clinical outcome
Secondary Outcomes
No secondary outcomes reported