Hartford, Connecticut 06016


Purpose:

This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.


Study summary:

Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling. However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.


Criteria:

Inclusion Criteria: - A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures. - Forearm fractures that require closed reduction (with or without conscious sedation) - Patients between the ages of 3 and 12 years old Exclusion Criteria: 1. Specific exclusions - Age less than 3 or greater than 12 - Patients presenting with an associated neurological or vascular injury caused by the fracture - Patients presenting with an open fracture - Patients requiring operative treatment following the initial fracture evaluation - Ipsilateral upper extremity fracture - Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort 2. Generic exclusion: "Subjects not meeting all inclusion criteria."


NCT ID:

NCT02614690


Primary Contact:

Principal Investigator
Mark Lee, MD
Connecticut Children's Medical Center

Mark Lee, MD
Phone: 860-545-9100
Email: Mlee01@connecticutchildrens.org


Backup Contact:

Email: Msolomito@connecticutchildrens.org
Matt Solomito
Phone: (860) 284-0208


Location Contact:

Hartford, Connecticut 06016
United States

Matt Solomito
Phone: 860-284-0208
Email: mailto:msolomito@ccmckids.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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