A Randomized, Prospective, Double-Blind Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps and Reducing Wound Complications After Complex Ventral Hernia Repairs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Number of Participants With Wound Complications
研究概览
简要总结
The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs. Complex ventral hernia repairs are associated with a high rate of wound complications. To a large degree these complications are caused by creating tissue advancement flaps to close the abdomen, which can compromise the blood supply to the skin and subcutaneous tissues. The current standard of care for assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however, often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite System is a device that enables surgeons to visualize and evaluate tissue perfusion in real time. It can help the surgeon to identify optimal flap design and reduce the risk of postoperative wound complications related to tissue ischemia. The primary goal of this study is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite System has been used successfully for assessing the viability of mastectomy flaps in breast surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis. However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral hernia repairs.
详细描述
More than 90,000 ventral hernia repairs are performed in the US annually. Large ventral hernias often require a complex abdominal wall reconstruction including creating tissue advancement flaps. Complex abdominal wall reconstructions are associated with up to 20% rate of wound complications including skin flap necrosis and wound breakdowns. Prevention of skin necrosis and ischemia would significantly reduce the morbidity associated with these procedures.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ventral hernia that will require tissue advancement flaps at time of hernia repair
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •ASA score IV or above
- •Age < 18 years
- •Patients with iodine allergy
- •Patients with current wound or mesh infection
- •Pregnant patients
- •Patients with End Stage Renal Disease
研究组 & 干预措施
Control - Blinded use of SPY Elite
Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
干预措施: Control - Blinded use of SPY Elite (Device)
SPY - Unblinded Use of SPY Elite
Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to whether or not their intraoperative Spy Elite imaging was used for operative planning. All patients will have digital photographs of the surgical wound taken by a blinded member of the surgical team daily until discharge, and on follow-up visits at one to two weeks, four weeks, and 12 weeks post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications.
干预措施: SPY - Unblinded use of SPY Elite (Device)
结局指标
主要结局
Number of Participants With Wound Complications
时间窗: 12 Weeks
breakdown, necrosis, erythema, infection, or dehiscence with location specified
次要结局
未报告次要终点