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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reduction of wound complications in the foot pump group
Study Overview
Brief Summary
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
Detailed Description
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who need an insitu bypass from Common Femoral Artery to Popliteal AK/BK or crural Artery
Exclusion Criteria
- •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-
Arms & Interventions
Foot pump (A-V Impulse, 6000 Series)
In OR before operation starts randomized to foot pump treatment post operative. Pump placed on foot immediately after operation is finished. Foot pump will be left on foot until full mobilization is reached
Intervention: A-V impulse 6000 Series (Device)
Standard treatment (compression)
In OR before operation starts randomized to standart treatment for edema after in situ bypass.
Short-stretch bandage from toes and up yo the upper thigh 40 mm Hg
Intervention: Standard treatment (compression) (Device)
Outcomes
Primary Outcomes
Reduction of wound complications in the foot pump group
Time Frame: 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
Secondary Outcomes
- Length of stay in hospital(10 to 14 Days)
- Reduction of leg edema 50%,(5 to 30 days)
- Time to mobilization in pump treated patients(1 to 7 days)
Investigators
Hans Ravn
Principal Investigator
Vejle Hospital