View clinical trials related to Syndactyly.
Filter by:This study aims to compare the functional results of two different therapeutic approaches in patients that present with a 5th metacarpal neck fracture. Patients will be randomly assigned to be treated with either syndactyly or closed reduction plus inmovilization.
Syndactyly is the most common hand abnormality in children. During development, two or more fingers do not separate in the usual way and remain connected by skin. Surgery is needed to separate the fingers. Usually, it is performed between 6 months and 3 years of age, depending on the severity of the syndactyly. During the surgery, the fingers are separated; however, there isn't enough skin to completely cover the fingers once they are separated. There are two areas on the fingers that need to be covered after separation, and there is a standard method, and now a new technique to cover these areas. The standard current technique that surgeons use to cover the newly separated fingers is to apply a small section of the patient's own skin taken from a different area of their body (this is known as a skin graft). A new technique called Hyaluronic acid matrix (Hyalomatrix®) is a U.S. Food and Drug Administration (FDA) approved, commercially available, skin graft substitute that is currently being used both in the US and in Europe. The Hyalomatrix (or skin graft substitute) is sutured into place using a stitch on each corner, over the areas left without skin covering during the surgery. The purpose of this study is to compare effectiveness, wound healing, scar formation and potential associated complications of the current skin graft technique with the new technique called Hyalomatrix (or skin graft substitute) following surgery.
Syndactyly is a relatively common congenital abnormality of the hand occurring approximately 1 out of 2500 live births (1). It can be simple, meaning only skin and soft tissues are shared, or complex, meaning the bone or nail parts are shared. In any case, it is a fact that there is not enough skin surrounding the two finger segment to be utilized to cover two separate fingers. This can also be proven by simple geometry. Therefore, it has always been taught to residents and explained to numerous patients' families that addition of skin graft is required for a proper syndactyly release. Without it, skin flaps would be too tight, causing some necrosis and significant scarring along the finger and particularly in the web space, causing an unsatisfactory functional and cosmetic result requiring revision.
Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell carcinomas in Gorlin's syndrome patients. Following a 21-day screening period, patients were exposed to multiple doses of topically applied LDE225 twice daily for 4 weeks in a double-blind manner. The patients returned weekly for visits where each BCC was clinically evaluated and digital photographs taken. Local safety and tolerability was also assessed. After the last application of treatment, biopsies were taken from treated (both vehicle and LDE225) BCCs (three per patient) for histology, biomarker evaluation and for pharmacokinetics (skin exposure). In addition, a biopsy from LDE225-treated uninvolved perilesional skin was taken for pharmacokinetic evaluation. In total, 4 biopsies were taken: 2 for histology and biomarker and 2 for PK. Part II of this study consisted of a 21-day screening period, a baseline period (directly before commencing the treatment period) and a treatment period of 6 or 9 weeks, depending on randomization. A clinical assessment was performed on site on the last treatment day and if a full clinical response had been observed, approximately 3 weeks after the last treatment an excision of the BCC(s) would have been performed. The study completion visit occurred either 1 week after the excision (when this visit was planned) or 1 week after the last treatment. For a subset of patients, skin biopsies were collected on the last treatment day and an excision of a BCC was also performed at that same visit.