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

Study Description

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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 Design

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

Arms and Interventions

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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.

Outcome Measures

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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.

Eligibility Criteria

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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

Contacts and Locations

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Contacts

Contact: Kari Williams, MPH	651-325-2316	KariAWilliams@gillettechildrens.com

Locations

United States, Minnesota
Gillette Children's Specialty Healthcare	Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Kari Williams, MPH 651-325-2316 KariAWilliams@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 - Clinical and Translational Science Institute

Investigators

Principal Investigator:	Ann Van Heest, MD	Gillette Children's Specialty Healthcare

More Information

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Publications:

Dao KD, Wood VE, Billings A. Treatment of syndactyly. Tech Hand Up Extrem Surg. 1998 Sep;2(3):166-77.

Perna RB, Loughan AR, Le JA, Hertza J. Prenatal and perinatal anesthesia and the long-term cognitive sequelae: a review. Appl Neuropsychol Child. 2015;4(1):65-71. doi: 10.1080/21622965.2013.779275. Epub 2013 Oct 24. Review.

Landi A, Garagnani L, Leti Acciaro A, Lando M, Ozben H, Gagliano MC. Hyaluronic acid scaffold for skin defects in congenital syndactyly release surgery: a novel technique based on the regenerative model. J Hand Surg Eur Vol. 2014 Nov;39(9):994-1000. doi: 10.1177/1753193414529046. Epub 2014 Mar 24.

Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7.

Crowe JM, Simpson K, Johnson W, Allen J. Reliability of photographic analysis in determining change in scar appearance. J Burn Care Rehabil. 1998 Mar-Apr;19(2):183-6.

Withey SJ, Kangesu T, Carver N, Sommerlad BC. The open finger technique for the release of syndactyly. J Hand Surg Br. 2001 Feb;26(1):4-7.

Responsible Party:	Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier:	NCT03107546 History of Changes
Other Study ID Numbers:	1703M09201
First Posted:	April 11, 2017
Last Update Posted:	August 8, 2017
Last Verified:	August 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No

Keywords provided by Gillette Children's Specialty Healthcare:

Syndactyly; Syndactyly release surgery; Full thickness skin graft; Hyalomatrix; Scar formation

Additional relevant MeSH terms:

Syndactyly; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases	Musculoskeletal Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities