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

NCT03107546 | Completed FDA Device

• 1 other identifier: 1703M09201
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Syndactyly

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  24 months

• 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.

  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.

  24 months

Secondary Outcomes (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.

  24 months

Study Arms (2)

Skin graft

OTHER

full thickness skin graft

Other: Skin graft

Hyalomatrix

EXPERIMENTAL

skin graft substitute

Device: Hyalomatrix

Interventions

Hyalomatrix DEVICE

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.

Hyalomatrix

Skin graft OTHER

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.

Skin graft

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Previous surgery on the web that requires a subsequent syndactyly release
• Diagnosis of macrodactyly

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead
• University of Minnesota: collaborator

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (6)

• Dao KD, Wood VE, Billings A. Treatment of syndactyly. Tech Hand Up Extrem Surg. 1998 Sep;2(3):166-77. doi: 10.1097/00130911-199809000-00004. No abstract available.

  PMID: 16801754 BACKGROUND

• 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.

  PMID: 24156239 BACKGROUND

• 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.

  PMID: 24664163 BACKGROUND

• 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. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

• 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. doi: 10.1097/00004630-199803000-00019.

  PMID: 9556325 BACKGROUND

• 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. doi: 10.1054/jhsb.2000.0575.

  PMID: 11162004 BACKGROUND

MeSH Terms

Conditions

Syndactyly

Interventions

Skin Transplantation

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Ann Van Heest, MD

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 11, 2017
• Study Start: May 11, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

US (1)