Negative Pressure Wound Therapy as a Drug Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound
研究概览
简要总结
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation.
详细描述
The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will be randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patients that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and will be evaluated in clinic every 7 days (±7 days) up to a total of 16-week period or until 30 days after the wound heals.
Study Procedures:
Screening Procedures
- Review and sign the Informed Consent and HIPAA Authorization
- The study doctor will review the inclusion and exclusion criteria
- Demographics (such as age, gender, race or ethnicity)
- Physical exam
- Sitting blood pressure and pulse
- Height and weight
- Collection of the medical and surgical history
- Collection of the history of the wound
- Wound assessment(s)/Debridement - various tests and measurements to assess the sensation (feeling) and circulation (blood flow) in the subject's feet and lower legs. None of these tests are invasive (using needles), uncomfortable or have risks greater than standard care.
- Wound imaging - photographs and images of the subject's wound using acetate tracings, a digital camera and an ARANZ camera (a special type of camera that uses computer software to calculate the volume of the wound)
- Hyperspectral imaging
- Vascular/Neurological evaluation
- Results of standard-of-care laboratory tests including a white blood cell count, blood chemistry (tests to see how well organs, such as the liver and kidneys are working), and blood glucose. Results of a serum pregnancy test (standard care for women of child-bearing potential as part of pre-op labs) will also be collected. About 2 tablespoons of blood will be drawn for these tests.
- Collection of a list of the subject's current medications, including prescriptions, over-the-counter medications, supplements and herbals.
This visit will last about 2 hours.
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
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus Men/women ≥21 years old Foot or ankle wounds sized 5 cm2 -100 cm2 ABI≥0.5 or toe pressures >30 mmHg
排除标准
- •Active Charcot arthropathy Unable to use NPWT at home Untreated bone or soft tissue infection Unable to keep research appointments Active alcohol or substance abuse
结局指标
主要结局
Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound
时间窗: 16 weeks
How many wounds fully healed in 16 weeks. Healing defined as fully epithelialized skin with no drainage.
次要结局
- Total Adverse Events of Participants(16 Weeks)
- Number of Participants With Wound Dehiscence After Hospital Discharge(16 weeks)
研究者
Larry Lavery
Professor, Department of Plastic Surgery
University of Texas Southwestern Medical Center