Comparison of Scar Formation in Syndactyly Release Surgery With Full Thickness Skin Graft Versus Skin Graft Substitute
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Background/Significance:
Syndactyly is a congenital condition where children are born with webbing between their fingers. Syndactyly is the most common congenital hand condition in Caucasian children. Treatment for syndactyly is a syndactyly separation surgery, most commonly between 6 months and 3 years of age, depending on the severity of the syndactyly.
Syndactyly release surgery is typically performed by rearranging skin on the fingers and hand to cover the separated digits. However, there is seldom enough skin to cover all surfaces after separation of the digits and 2 similarly size defects are left, one at the base of each finger. The gold standard for covering these remaining defects has been full-thickness autograft skin. However, harvesting the graft, closing the defect at the harvest site and suturing the grafts into place requires considerable time (the investigators estimate a total of 60 minutes per web space). With recent concerns arising over prolonged anesthesia and brain development in young children, pediatric surgeons are searching for ways to limit anesthesia exposure. In addition to the prolonged anesthesia time for harvesting and suturing the autograft, the donor site is left with a scar that could be avoided if a skin graft substitute were available.
Hyaluronic acid matrix (Hyalomatrix®) is a FDA approved, commercially available, relatively inexpensive skin graft substitute. Each 1 inch by 1 inch sheet costs approximately $250.00 and could be used to cover both defects in most cases. It is sutured into place over a defect with a stitch on each corner. Although good results for use of HA matrix in syndactyly surgery have been reported in the European literature, no comparison has been made with the gold standard full thickness skin autograft.
Purpose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •Previous surgery on the web that requires a subsequent syndactyly release
- •Diagnosis of macrodactyly
- •Those who otherwise do not meet the inclusion criteria
结局指标
主要结局
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
时间窗: 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.
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.
时间窗: 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.
次要结局
- 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)