A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
University of Wisconsin, Madison
Summary
The purpose of this study is to assess if the application of Mastisol, a liquid adhesive, improves outcomes during bilateral clubfoot casting and reduces complications and development of complex clubfoot for the duration of their casting and up to 5 years follow-up.
Description
Study Objectives include: * Determine if application of Mastisol is associated with improved clubfoot outcomes including length of treatment, recurrence of clubfoot, and reconstruction of clubfoot. * Assess if the application of Mastisol prior to cast placement is associated with reduced cast slippage and other complications such as severe skin irritation, sores, and development of complex clubfoot. The investigators hypothesize that Mastisol application will be associated with improved outcomes by helping to maintain a well-fitting cast, which can be key to reducing complications, optimizin…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with bilateral clubfeet * Starting standard of care treatment with the Ponseti method between 0-12 weeks of age * For patients born pre-maturely their eligibility age will be based on a corrected gestational age * Patients for whom at least one parent/guardian is able to converse, read, and write in English Exclusion Criteria: * Patients who do not have bilateral clubfoot * Patients who are starting treatment for clubfoot after 12 weeks of age * Patients whose parents/guardians are unable to converse, read, and write in English * Patients whose parents/guar…
Interventions
- DeviceMastisol
a liquid adhesive used to secure dressings for extended periods of time
Location
- UW-Health Pediatric Orthopedics ClinicsMadison, Wisconsin