UW-Health Pediatric Orthopedics Clinics
Madison, Wisconsin, 53792, United States
Location status: Recruiting
NCT Number: NCT07154550
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.
Interested in participating?
Request Info0 week–12 week
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
Location status: Recruiting
Study Objectives include:
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, optimizing correction (i.e. minimizing treatment time). Proper correction can ultimately be associated with decreased incidence of clubfoot recurrence and need for reconstruction.
Participants' participation will last roughly 8-12 weeks but may be shorter or longer depending on their response to manipulation and casting. This is a standard expectation with the Ponseti method of clubfoot casting.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a liquid adhesive used to secure dressings for extended periods of time
Other names: Mastisol Liquid Adhesive
Time frame: up to 12 weeks
Time frame: follow up to 5 years from medical records
Time frame: follow up to 5 years from medical records
Time frame: up to 12 weeks
Time frame: up to 12 weeks
Time frame: up to 12 weeks
Time frame: up to 12 weeks
Time frame: up to 12 weeks
sores, redness, swelling, irritation, obvious slippage
Time frame: up to 12 weeks
severe dermatitis
Time frame: up to 12 weeks
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
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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