Syndactyly Repair: Comparison of Skin Graft and No Skin Graft Techniques

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Douglas Hutchinson, University of Utah
ClinicalTrials.gov Identifier:
NCT01416090
First received: August 10, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

Syndactyly is a relatively common congenital abnormality of the hand occurring approximately 1 out of 2500 live births (1). It can be simple, meaning only skin and soft tissues are shared, or complex, meaning the bone or nail parts are shared. In any case, it is a fact that there is not enough skin surrounding the two finger segment to be utilized to cover two separate fingers. This can also be proven by simple geometry. Therefore, it has always been taught to residents and explained to numerous patients' families that addition of skin graft is required for a proper syndactyly release. Without it, skin flaps would be too tight, causing some necrosis and significant scarring along the finger and particularly in the web space, causing an unsatisfactory functional and cosmetic result requiring revision.


Condition
Congenital Hand Deformities

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Syndactyly Repair: Comparison of Skin Graft and No Skin Graft Techniques

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • compare this newer technique to the gold standard full thickness skin graft technique [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Patients will all be treated with the same post-operative dressing and the same post-operative protocol. They will be followed in the same manner, approximately one month from surgery when the dressings will be removed, three months from surgery and then yearly. Final assessment, including the objective testing of their fingers, will be performed by an independent therapist experienced in congenital pediatric patients.


Estimated Enrollment: 30
Study Start Date: July 2004
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Syndactyly is a relatively common congenital abnormality of the hand occurring approximately 1 out of 2500 live births (1). It can be simple, meaning only skin and soft tissues are shared, or complex, meaning the bone or nail parts are shared. In any case, it is a fact that there is not enough skin surrounding the two finger segment to be utilized to cover two separate fingers. This can also be proven by simple geometry. Therefore, it has always been taught to residents and explained to numerous patients' families that addition of skin graft is required for a proper syndactyly release. Without it, skin flaps would be too tight, causing some necrosis and significant scarring along the finger and particularly in the web space, causing an unsatisfactory functional and cosmetic result requiring revision.

Full thickness skin grafts (FTSG) are usually utilized for this procedure and come at some cost. An additional incision, and therefore scar, is made in the groin or on the arm or hand itself. The skin graft itself usually has a slightly different color and further hyperpigments (2, 3, 4, 5) when placed on the hand and can have hair growth that would not normally be present between fingers. These create cosmetic issues as the patient gets older. In addition, skin graft is quite cumbersome to utilize in these tight areas and small fingers of small children. It definitely adds to the time under anesthesia because no method other than sewing with small sutures has been shown to be efficacious. Whereas the release of a simple syndactyly may take 30-60 minutes, the suturing of skin graft and the skin flaps usually takes one and half times that long in addition. Further, skin grafts require immobilization and special bandaging techniques to avoid graft loss. One final disadvantage of full thickness skin grafts is that they have been implicated in the occurrence of web creep, which is a post-operative scarring between fingers that decreases the amount of web space originally obtained (4,6). These will often require further surgical procedures (Percival & Sykes).

Over the last 20 years, there has been resurgence in attempts to treat syndactyly without skin grafts (8, 9, 10, 11, 12, 3, 6). All techniques include a significant defatting of the subcutaneous tissues all the way back to the web space in an effect to decrease circumference of the digits. Different dorsal metacarpal flaps have been described as well, including local island pedicle flaps that can be used for the web commissure (3, 9, 10, 11). In addition, it has been shown that leaving flaps slightly open, up to 2mm, for secondary intention healing creates good scars in children and no increased sign of web creep or flexion contracture (5). Combining all three of these techniques leads to the technical ability of syndactyly release without the need for skin grafts. Proven benefits have been the lack of the donor scar, lack of pigmented or hairy graft sites, and decreased operative time. However, the incidences of web creep, flexion or lateral contractures, reoperation rate and the final cosmetic result have not been proven to be better or worse, as no one has compared similar patients. All studies to date have been instead a review of results using their particular technique that does not require skin graft. If any comparisons have been made, it has been using historical data already published.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Syndactyly is a relatively common congenital abnormality of the hand occurring approximately 1 out of 2500 live births. We will utilize children under the age of 6 years and over the age of 6 months. Most will likely be less than 2.5 years of age. This surgery is usually performed when the patient is still a child.

Criteria

Inclusion Criteria:

  • Children ages 6 months to 6 years with simple syndactyly 2nd and/or 3rd web space without other major congenital hand abnormally syndrome that would affect growth, function, and appearance of hand.

Exclusion Criteria:

  • patients with complex syndactyly, syndactyly of teh first web, patients with brachysyndactyly and diagnosis of Apert's, poland's and other syndromes that often include incomplete digital components and subsequent function.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01416090

Locations
United States, Utah
University of Utah Orthopedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Douglas T Hutchinson, M.D. University of Utah Orthopedic Center
  More Information

No publications provided

Responsible Party: Douglas Hutchinson, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01416090     History of Changes
Other Study ID Numbers: 12534
Study First Received: August 10, 2011
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
syndactyly

Additional relevant MeSH terms:
Congenital Abnormalities
Hand Deformities
Hand Deformities, Congenital
Syndactyly
Musculoskeletal Diseases
Upper Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases

ClinicalTrials.gov processed this record on August 28, 2014