Impact on Expected Post-operative Complications With Impulsive Compression of Vein Complexes in Foot of Patients Operated on With In-situ Bypass for Acute/Chronic Leg Ischemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of wound complications in the foot pump group
研究概览
简要总结
To investigate whether compression therapy with foot pump reduce post-operative edema, facilitate wound healing of operation wounds, promote healing of ischemic ulcers and shorten hospitalization, increase and improve the patient's subjective quality of life faster
详细描述
Impact on expected post-operative complications with impulsive compression of vein complexes in foot of patient operated on with insitu bypass for acute/chronic leg ischemia.
Purpose/aim:
To investigate whether compression therapy with foot pump reduce post-operative edema, facilitate wound healing of the operation wounds, promote healing of ischemic ulcers and shorten hospitalization, increase and improve the patient's subjective quality of life faster.
Background:
Insitu bypass to the lower extremity are the standard operation choice on patients with critical leg ischemia. Approximately 18% of patients wound problems, which prolong their hospitalization time and convalescence. One of the reasons for wound problems is swelling, which occurs in connection with the legs process of revascularization (angiogenesis). One can expect that the leg, 10 cm below the patella will undergo swelling with approximately 6-8% during the first day, and up to 8-10% after four days in connection with the inset bypass surgery. Early mobilization can prevent the swelling to become too pronounced. By mobilizing you stimulate the natural venous pump in the leg. Patients are often hard to mobilize in an early stage due to the wound and age. Stimulation of the venous plexus in the arch of the foot has in other categories of patients shown to reduce swellings of leg and thrombosis risk in patients undergoing orthopedic surgery on the lower extremities .
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need an insitu bypass from Common Femoral Artery to Popliteal AK/BK or crural Artery
排除标准
- •Ischemic wound that are located in such manner that compression of the foot is not possible. Former deep vein trombosis (DVT) or symptomatic post thrombotic syndrome (PTS) We only include patients without any connections to other studies-
结局指标
主要结局
Reduction of wound complications in the foot pump group
时间窗: From randomization until 12 month examination (individual finish examination)
reduction from 18% to 14 %.Inspection of the operated leg at day 2 and 4 and at discharging. After discharging at 30 days, 6 month and one year.More frequent inspections can be necessary depending on the situation and the condition of the patient. Inspection of secretion from the operations cicatrices, necrosis and diastasis of the wounds, signs of infections, hematoma subcutaneously in the operation area, edema, temperature and color of the skin
次要结局
- Reduction of leg edema 50%,(5 to 30 days)
- Time to mobilization in pump treated patients(1 to 7 days)
- Length of stay in hospital(10 to 14 Days)
研究者
Hans Ravn
Principal Investigator
Vejle Hospital
