Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Completed
NCT Number: NCT06102603
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children
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.
Completed
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Notify MeKey information
Conditions
Age range
4 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
the biobased polyester cast
Otherlong arm casting
the synthetic fiberglass cast
Otherlong arm casting
Primary outcomes
-
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
-
patient satisfaction questionnaire
Time frame: one month after intervention
Sponsors and collaborators
Lead sponsor
Far Eastern Memorial Hospital
Other
Registry information
Official study title
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Oct 26, 2023
- Registry last updated
- Oct 30, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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