Multi-Institutional Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Anterolateral Thigh Donor Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Total Drain Output
研究概览
简要总结
This is a single-blinded multi-institutional randomized controlled trial to evaluate the effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor sites. Increased drainage from donor sites can lead to seroma formation with possible secondary infection, delayed hospital discharge, and additional home care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic powder that can be easily applied to broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to free flap donor sites may bear significant potential benefit.
Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs and time to drain removal compared to ALT donor sites closed without Arista.
Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will reduce postoperative ALT donor site seromas and patient hospital length of stay.
详细描述
Free tissue transfer is a commonly performed procedure, especially at tertiary care hospitals. In free tissue transfer, "spare tissue" from one area of the body (donor site) is re-implanted to an area that is need of reconstruction (defect site). When relocated, the "spare tissue" is given vitality and blood supply at its new location by microscopically sewing and connecting its feeding artery and vein to an artery and vein in or near the defect site. Hence, this operation is referred to as "microvascular free tissue transfer" or "free flap". Defect sites most commonly result from tumor or cancer removal and trauma related injuries. Free flaps are frequently used to reconstruct breast tissue after mastectomy, head and neck cancer resections, extremity injuries, and chronically infected wounds. The indications, utilization, and expertise in free flap surgery continue to grow, providing patients with enhanced outcomes of otherwise difficult cancers and wounds.
Since its original description in 1984 the ALT microvascular free flap has become an increasingly integral part of head and neck reconstructive surgery.1, 2 ALT free flaps have been shown to be a reliable method for several reconstructive procedures with minimal donor site morbidity.2-4 The ALT free flap is composed of skin, subcutaneous tissue, and fat of the anterolateral thigh. The blood supply to this area is from the lateral circumflex femoral artery and vein. These vessels along with the tissues of the anterolateral thigh are carefully dissected and removed as a single unit to be re-implanted in a different part of the body.
Multiple options exist for soft tissue free flap donor sites similar to the ALT. However, a distinct advantage of the ALT free flap over others is the minimal donor site morbidity that the patient undergoes. Patients are able to fully ambulate and function after the surgery, and are left with only a well-healed scar line. Despite its many advantages, postoperative fluid collections continue to be problematic in the ALT donor site. Studies have reported seroma rates in ALT donor sites as high as 5% although this likely underestimates the true incidence of clinically significant postoperative fluid collections and wound complications in this patient population.2 ALT free flaps require a large amount of tissue dissection and removal, creating a large potential space in the lateral thigh that often requires prolonged postoperative suction drainage and pressure dressings in efforts to minimize fluid accumulation.
Research in optimal postoperative management for the ALT donor site is lacking. Current management without the use of Arista often requires a surgical drain for 7-14 days, which can delay patient discharge and expose patients to increased risk of postoperative wound infections. There is a paucity of data on methods to reduce ALT donor site drain output and seromas. Surgeons often use a combination of closed suction surgical drains and pressure dressings to try and reduce the amount of fluid collection in the thigh donor sites. Although this does provide some advantage, if these techniques are required for a prolonged time, unnecessary hospital stay and patient morbidity are attained. According the Healthcare Cost and Utilization Project, an average inpatient hospitalization in 2009 cost $2,000 per day, and is increasing.5 If the use of a single bottle of Arista could reduce just 1 hospital day per patient it could save at least $80,000 dollars a year at our department alone. Further, the associated morbidity and health care costs of potential seroma or infected seroma complications may be avoided.
A randomized controlled trial aimed at evaluating improved methods to reduce postoperative drainage from ALT donor sites could provide critical information on how to best serve our patients, eliminate unnecessary hospital stay, and reduce overall cost. Once studied in a controlled single flap environment, these methods could be then expanded to other or all free flap donor sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing ALT free tissue transfer for head and neck reconstruction
- •Patient must be 18 years of age or older.
- •The patient must have capacity to be able to sign a study-specific informed consent prior to study entry.
排除标准
- •Pregnancy (for female patients).
- •Patients who will require anticoagulant medications other than routine DVT prophylaxis within 8 days postoperatively.
- •Presence of clotting or bleeding disorder.
结局指标
主要结局
Total Drain Output
时间窗: 1-14 days after Surgery
The primary outcome analyzed in this study will be total drain output (mL) in an effort to determine if the addition of Arista to the wound bed decreases overall wound drainage and drain output.
Number of Participants With the Development of ALT Donor Site Seroma
时间窗: 30 days postoperative
ALT donor site will be evaluated for seroma
Timing to Drain Removal
时间窗: 30 days postoperative
Given that drain output influences time of drain removal, assessment will be made to determine if timing of drain removal differs between groups.
次要结局
- Hospital Length of Stay(30 days postoperative)
