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临床试验/NCT01416090
NCT01416090已完成不适用

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

University of Utah1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
compare this newer technique to the gold standard full thickness skin graft technique

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

compare this newer technique to the gold standard full thickness skin graft technique

时间窗: 5 years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Hutchinson

M.D.

University of Utah

研究点 (1)

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