Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Syndactyly, sponsored by Gillette Children's Specialty Healthcare.
NCT03107546 is a NA study of Syndactyly that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The difference in scar quality between Hyalomatrix and full thickness skin graft will be assessed by the POSAS and the Hamilton Photographic Scar Assessment Scales at 8 weeks, 6 months, 12 months and 24 months after surgery. These scales assess the thickness, color (darkness), pliability, appearance, and vascularity (redness) of a scar compared to normal skin and includes assessments by both the investigators and participant/caregiver. Wilcoxon signed-rank tests will be utilized to compare total
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 |
What the finished NCT03107546 record still lists
NCT03107546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03107546's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI