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Comparison of Scar Formation in Syndactyly Release Surgery With Full Thickness Skin Graft Versus Skin Graft Substitute

NCT03107546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-03-23

No results posted yet for this 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

  • Syndactyly

Interventions

DEVICE

Hyalomatrix

We are comparing two techniques for covering the open area of the finger at the end of syndactyly release surgery. We would like to compare the current technique, a skin graft, with a new technique called Hyalomatrix.

OTHER

Skin graft

We are comparing two techniques for covering the open area of the finger at the end of syndactyly release surgery. We would like to compare the current technique, a skin graft, with a new technique called Hyalomatrix.

Sponsors & Collaborators

Principal Investigators

  • Ann Van Heest, MD · Gillette Children's Specialty Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107546 on ClinicalTrials.gov