Direct Application of Integra Bilayer Matrices on Bare Calvarium Without Preliminary Burring: A Clinical and Histologic Study of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Time to complete closure
研究概览
简要总结
This study is to determine if large, full thickness scalp wounds with exposed calvarium resulting from acutely created extirpative defects can be reliably and durably resurfaced with IDRT without burring or fenestration as a preliminary step, regardless of the size of the calvarial defect.
详细描述
Large full thickness scalp wounds often present a reconstructive challenge, as the size of the defect and the presence of denuded bone often preclude local flap options and skin grafting as methods of coverage. Integra dermal regeneration template (IDRT) has shown great utility in these types of wounds due to its ability to take in wounds with diminished vascularity, but the limits of this ability have not been determined. When used for full thickness scalp defects with exposed calvarium, for example, the accepted practice is that burring of the outer table to gain access to the vascularized diploic space is a necessary prerequisite step, although this is not always possible or desirable. The clinical question being investigated is whether healthy calvarium is sufficient for durable IDRT and subsequent skin graft take in wounds with a large surface area of denuded calvarium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study design is a single-arm prospective pilot study with all patient receiving the IDRT wound care device.
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any full-thickness scalp wound extending to the cranium, devoid of pericranium that is:
- •greater than or equal to 2 cm and/or is deemed by the treating physician not to be amenable to closure by simple means, primary closure or local flap.
- •occurring in as elder patient > 55 years old with co-morbid conditions that constitute and anesthetic risk (ASA) >=3 that demonstrates punctate bleeding from healthy appearing cortical bone following debridement/extirpation
排除标准
- •hypersensitivity of bovine collagen and/or chondroitin
- •previous treatment under same protocol
- •current or planned treatment/medication know to interfere with the rate and quality of wound healing.
- •suspected signs of wound infection
- •suspected/known diagnosis of osteomyelitis, osteoradionecrosis, or non-availability of cortical bone
- •anticipated defect following debridement or tumor extirpation extending past the outer cortical layer or cranium
- •history of radiation to the field
- •history of other conditions/illness compromising the wound healing process (ESRD, immunosuppression),
- •absence of punctate cortical bleeding
- •prior surgeries that would be expected to impair wound healing or vascularity of the underlying bone(e.g. history of craniectomy/bone flap, history of scalp flap/VP shunt.
结局指标
主要结局
Time to complete closure
时间窗: 10 - 12 months for study
Time to complete closure (in days), as assessed by full re-epithelialization
Percentage of subjects with complete closure of defect
时间窗: 10 - 12 months for study
Percentage of subjects with complete closure of defect
次要结局
- Percent overall skin graft take(Follow-up of each patient is 6/months.)
研究者
Joshua Choo
Assistant Professor, M.D.
University of Louisville