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

Congenital Hand Deformities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416090
• Other study ID #: 12534
• Status: Completed
• Start date: July 2004
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hand Deformities
• Hand Deformities
• Hand Deformities, Congenital
• Syndactyly

Locations

Country	Name	City	State
United States	University of Utah Orthopedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare this newer technique to the gold standard full thickness skin graft technique	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.	5 years