Prospective Randomized Control Trial Comparing Two Methods of Negative Pressure Wound Therapy: Gauze Suction Versus Vacuum Assisted Closure Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Percent Change Per Day in Wound Surface Area
研究概览
简要总结
The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is effective but has some drawbacks:
- The system is expensive.
- There us conflicting data about the effectiveness of VAC therapy for infected wounds.
- VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid drainage, and in wounds near body orifices.
Over the past 4 years, we have accumulated additional experience with negative pressure wound therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call this method G-SUC and have used it when we have been unable to maintain a dressing seal with the VAC system (due to excess drainage or wound location), for management if infected wounds. We have found this method to be effective without any specific negative side effects.
Our specific aims are:
- Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each method will include the proportional change in wound size over 1 - 2 weeks.
- Compare the effectiveness of G-SUC and VAC system in controlling wound infections as measured by the number of patients who are able to clear infection by 4 days.
- Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction.
- Measure and compare the cost of wound treatment with the two methods including direct cost and time spent at the bed side performing the dressing change.
Our hypotheses are:
- G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting.
- G-SUC is more effective than VAC for management of infected wounds.
- G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot.
- Negative pressure therapy with G-SUC is less costly than VAC.
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
- None
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
- •Hospitalized patients at the University of Chicago Medical Center with acute wounds resulting from ether trauma, dehiscence or surgical complications
排除标准
- •Patients with systemic sepsis caused by wound infection
- •Those with grossly necrotic wounds
- •Malignancy in the wound
- •Wounds with untreated osteomyelitis
- •Patients with allergy to sulfamylon and Dakin's (sodium hypochlorite) Patients with 2 first criteria would become eligible once their sepsis resolves and/or necrotic tissue has been debrided from the wound.
研究组 & 干预措施
G-SUC
Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
干预措施: Gauze suction (G-SUC) (Device)
Vacuum Assisted Closure
Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
干预措施: Vacuum Assisted Closure Device (VAC) (Device)
结局指标
主要结局
Percent Change Per Day in Wound Surface Area
时间窗: 7 days
Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Percent Change Per Day in Wound Volume
时间窗: 7 days
Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
次要结局
- Failure to Maintain Dressing Because of Fluid or Suction Leaks(Participants were followed for the duration of inpatient stay, an average of 5 days.)
- Average Time Spent on Dressing Changes(Participants were followed for the duration of inpatient stay, an average of 5 days.)
- Pain Score With Dressing Changes(Participants were followed for the duration of inpatient stay, an average of 5 days.)
- Average Cost of Supplies and Rental(Participants were followed for the duration of inpatient stay, an average of 5 days.)