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Trial record 2 of 3 for:    hyalomatrix

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

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ClinicalTrials.gov Identifier: NCT03107546
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Gillette Children's Specialty Healthcare

Brief 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.


Condition or disease Intervention/treatment Phase
Syndactyly Device: Hyalomatrix Other: Skin graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Sample:

The overall recruitment goal for the study is 40 participants within the first 5 years of the study.

For phase one, a sample size of 10 participants is the goal, and the investigators anticipate that this will take at most 18 months to attain based on their historical data.

For phase two, the investigators anticipate 30 months will be required to accumulate a sample size of 30 additional participants. Recruitment for phase two is expected to begin in year 2. Issues identified in the feasibility phase will be addressed as needed and the protocol amended.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: The location of each (i.e., radial or ulnar side of the web) will be randomized and blinded. The participant and family will be blinded to which side of the web receives either the full-thickness graft or the skin substitute
Primary Purpose: Treatment
Official Title: Comparison of Scar Formation in Syndactyly Release Surgery With Full Thickness Skin Graft Versus Skin Graft Substitute
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Skin graft
full thickness skin graft
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.

Experimental: Hyalomatrix
skin graft substitute
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.




Primary Outcome Measures :
  1. Difference in scar quality between Hyalomatrix® and full-thickness skin graft when used during syndactyly release surgery as assessed by the Patient/Parent and Observer Scar Assessment Scale (POSAS) and the Hamilton Photographic Scar Assessment Scale [ Time Frame: 24 months ]
    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 scores for the Hyalomatrix and the full-thickness skin graft as matched pairs over time.

  2. Difference in web creeping between Hyalomatrix® and full-thickness skin graft when used during syndactyly release surgery as assessed by the Web Creep Assessment Scale. [ Time Frame: 24 months ]
    The difference in web creeping between Hyalomatrix and full thickness skin graft will be assessed by the Web Creep Assessment Scale. This scale will be assessed by the investigators using photographs of the participant's hands. Photographs will be taken at immediately pre-surgery, immediate post-surgery, 8 weeks, 6 months, 12 months and 24 months. Wilcoxon signed-rank tests will be utilized to compare total scores for the Hyalomatrix and the full-thickness skin graft as matched pairs over time.


Secondary Outcome Measures :
  1. Analysis of the participants' demographic, clinical and surgical data to see if there is any difference between the Hyalomatrix® and full-thickness skin graft groups. [ Time Frame: 24 months ]
    Descriptive statistics will be used to analyze the participants' demographic, clinical and surgical data.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients under the age of 18 years who require syndactyly release surgery with skin grafting for one, or more, web spaces on their hand(s) will be eligible for this study
  2. Those who have had a previous syndactyly release surgery on one or more webs will still be considered for inclusion if the current web requiring syndactyly surgery has not been previously operated on

Exclusion Criteria:

  1. Previous surgery on the web that requires a subsequent syndactyly release
  2. Diagnosis of macrodactyly
  3. Those who otherwise do not meet the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107546


Contacts
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Contact: Heather Wendorf, MPH 651-325-2314 HWendorf@gillettechildrens.com

Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Heather Wendorf, MPH    651-325-2314    HWendorf@gillettechildrens.com   
Contact: Ann Van Heest, MD    651-578-5061    vanhe003@umn.edu   
Principal Investigator: Ann Van Heest, MD         
Sub-Investigator: Deborah Bohn, MD         
Sub-Investigator: Amy Moeller, MD         
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
University of Minnesota
Investigators
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Principal Investigator: Ann Van Heest, MD Gillette Children's Specialty Healthcare
Publications:
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Responsible Party: Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT03107546    
Other Study ID Numbers: 1703M09201
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Gillette Children's Specialty Healthcare:
Syndactyly
Syndactyly release surgery
Full thickness skin graft
Hyalomatrix
Scar formation
Additional relevant MeSH terms:
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Syndactyly
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities