A Novel Application of Closed Incision Negative Pressure Wound Therapy for the Post-Surgical Management of Lower Extremity Amputations: A Randomized Clinical Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
研究概览
简要总结
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression wrapping and wound care post-LEA.
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
详细描述
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy (CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation (LEA) compared with standard of care compression wrapping and wound care post-LEA.
Specific objectives:
- Collect demographics and relevant data (e.g., risk factors and comorbidities) to compare intervention and control groups.
- Measure post-surgical outcomes and compare both groups.
STUDY DESIGN
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
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
- 是
入选标准
- •to select the participants (intervention and control):
- •Individual aged 18 years or older
- •Individual with a closed incision following LEA (transmetatarsal or proximal)
- •Individual presents with adequate perfusion based on WIfI ischemia component score of less than 2 (>30mm Hg TCPO2 or higher at region of amputation)
- •Individual presents with no residual surgical site infection (WIfI grade 0) post LEA
- •Individual is competent to make their own medical decisions
排除标准
- •(intervention and control):
- •Individual presents with any defined contraindications to NPWT (e.g., allergy).
- •Individual presents with residual acute osteomyelitis (after amputation).
- •Individual with collagen vascular disease or malignant disease in the wound
- •Individual has uncontrolled hyperglycemia (glycosylated hemoglobin [HbA1c]>12%).
- •Individual is currently taking corticosteroids, immunosuppressive drugs, or chemotherapy and is not on stable course of therapy as determined by principal investigator
- •Individual has a history of local radiation therapy that could impact the edema of the amputated limb.
- •Individual has pre-existing conditions contributing to residual limb edema (i.e., nephropathy, congestive heart failure, primary lymphedema, etc.).
- •Withdrawal of individuals:
- •Voluntary withdrawal
- •Lost to follow-up
- •Termination of compression therapy (control or intervention group)
研究组 & 干预措施
Control group: Standard of Care
Following amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily.
干预措施: Standard of Care group (Procedure)
CiNPWT treatment group
Following amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as ~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days.
A patient may always be removed from treatment intervention whenever they wish.
干预措施: CINPWT (Device)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
时间窗: Up to 8 weeks
CiNPWT on number of needed physical therapy visits, adverse events, surgical site infection, re-amputation/revision rate, dehiscence, dressing failure, unscheduled/emergency encounters, hospital-acquired pressure injuries.
Number of participants with reduction of edema as assessed using Girth measurements and Grading system.
时间窗: Up to 8 weeks
Measurement of edema reduction using the +1 to +4 grading system as well as girth measurements of lower extremity of using measuring tape.
Number of participants with Greater acceptability, tolerability and convenience as assessed by Short Form 36 and patient provided feedback.
时间窗: Up to 8 weeks
Determine the overall tolerability, acceptability, and convenience of the intervention using Patient surveys and patient provided feedback.
Number of participants with shorter time to ambulation and weight-bearing as measured by a stopwatch.
时间窗: Up to 8 weeks
CiNPWT effect on ambulation by measuring time to ambulation, time to weight-bearing as measured by a stopwatch.
次要结局
未报告次要终点
研究者
David Armstrong
Dr. David Armstrong DPM, MD, PhD, Principal Investigator
University of Southern California