Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: VAC and GSUC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Percentage of Wounds With Complete Skin Graft Take
研究概览
简要总结
The purpose of this study is to compare how well two methods (VAC and G-SUC) of securing skin grafts using negative pressure wound therapy work. Negative pressure wound therapy is a commonly used method of applying suction on wounds to remove fluid from wound and to promote healing. The VAC system is widely used and consists of a foam dressing and a portable computerized suction pump. The G-SUC method uses commonly available dressing supplies attached to vacuum (suction) pump located on the wall above a hospital bed. The investigators have frequently used both methods over the past 10 years and have not observed any specific negative side effects of either.
详细描述
STUDY DESIGN: A prospective, randomized study will be conducted. The investigators expect the duration of data collection to be 2 years.
- PATIENT SELECTION
Adult patients of any sex, hospitalized at the University of Chicago Medical Center, requiring split thickness skin autografts with wounds that are amenable to placement of an occlusive dressing for negative pressure therapy will be eligible to participate in the study. If both the patient and the primary treating surgeon agree to participate, they will receive informed consent. Pregnant women, children under 18 years of age and other patients who are "vulnerable" as defined by the Institutional Review Board will not be eligible for the study. 2. STUDY PROCEDURE
Preoperative Procedures:
Patients with wounds requiring skin grafting will enter the trial upon consent of the patient and the preoperative decision by the surgeon to secure the skin graft with negative pressure therapy. Upon entry, the primary physical therapist will be immediately informed of a study participant and will place either the G-SUC or VAC dressing at the conclusion of the operation. The randomization scheme will be prepared by the study statistician using computer generated random numbers. The surgeon will be blinded to the treatment modality until the primary physical therapist places the randomized therapy.
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
- 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
- •Adult patients of any sex, hospitalized at the University of Chicago Medical Center, requiring split thickness skin autografts with wounds that are amenable to placement of an occlusive dressing for negative pressure therapy will be eligible to participate in the study
排除标准
- •Pregnant women, children under 18 years of age and other patients who are "vulnerable" as defined by the Institutional Review Board will not be eligible for the study
研究组 & 干预措施
GSUC
Gauze-based wall suction negative pressure wound therapy for 4-5 days
干预措施: GSUC (Device)
Vacuum-assisted closure
Vacuum-assisted closure (VAC) negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days
干预措施: VAC (Device)
结局指标
主要结局
Percentage of Wounds With Complete Skin Graft Take
时间窗: Day 4 or 5
For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.
次要结局
- Percentage of Wounds With Total Skin Graft Loss(Day 4 or 5)
