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NCT03107546 · ClinicalTrials.gov registry record · NA
Comparison of Scar Formation in Syndactyly Release Surgery With Full Thickness Skin Graft Versus Skin Graft Substitute
A NA study of Syndactyly, sponsored by Gillette Children's Specialty Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03107546 is a NA study of Syndactyly that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 19 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03107546, a NA study of Syndactyly, has completed, sponsored by Gillette Children's Specialty Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Hyalomatrix
- OTHER Skin graft
Study Locations (1)
Minnesota
- Gillette Children's Specialty Healthcare - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03107546
The ClinicalTrials.gov registry entry for NCT03107546 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gillette Children's Specialty Healthcare, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Syndactyly appearing as the primary indexed condition, and to 2 interventions - of which Hyalomatrix is the first listed.
NCT03107546 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT03107546 about?
NCT03107546 is a clinical study titled "Comparison of Scar Formation in Syndactyly Release Surgery With Full Thickness Skin Graft Versus Skin Graft Substitute". 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...
What is the current status of trial NCT03107546?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2017-05-11. Estimated completion is 2022-12-31.
What conditions does trial NCT03107546 study?
This clinical trial studies the following conditions: Syndactyly.
What interventions are being tested in trial NCT03107546?
The interventions under investigation include: Hyalomatrix (DEVICE), Skin graft (OTHER).
Who is sponsoring clinical trial NCT03107546?
This trial is sponsored by Gillette Children's Specialty Healthcare, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03107546 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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