跳至主要内容
临床试验/NCT03192982
NCT03192982Unknown不适用

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

Kolding Sygehus2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2月8日最近更新:
适应症

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

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

发起方
Kolding Sygehus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Ravn

Principal Investigator

Vejle Hospital

研究点 (2)

Loading locations...

相似试验

尚未招募
4 期
Compression Therapy for Swelling Management Following Ankle InjuryAnkle ArthrodesisAnkle Fracture
NCT06772649Nova Scotia Health Authority50
撤回
不适用
Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?Varicose VeinVenous Insufficiency
NCT02241707NYC Surgical Associates
尚未招募
不适用
se of foot pumps: effects on reduction of swelling and venous flow in the lower extremitymulti-orgaanfalenleg oedemaleg swelling
NL-OMON31478Academisch Medisch Centrum60
撤回
不适用
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After ChemoradiationClinical Stage II HPV-Mediated (p16-pos) Oropharyngeal CarcinomaClinical Stage III HPV-Mediated (p16-pos) Oropharyngeal CarcinomaClinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal CarcinomaHead and Neck CarcinomaStage II Hypopharyngeal Carcinoma AJCC v8Stage II Laryngeal Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
NCT05512767Mayo Clinic
已完成
不适用
Quantification and Characterization of Foot Postoperative EdemaSurgery--Complications
NCT05190835Clinique MEGIVAL100