Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-operative Complication, Impulsive Compression, in Situ Bypass (50506)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03192982
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hans Ravn, Vejle Hospital

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

Condition or disease Intervention/treatment Phase
Compresion Therapy Post-operative Edema Wound Complication Ischemia Limb Quality of Life Device: A-V impulse 6000 Series Device: Standard treatment (compression) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: A-V impulse 6000 Series
foot pad and pump

Active Comparator: 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

Device: Standard treatment (compression)
Short-stretch bandage from toes and up yo the upper thigh 40 mm Hg




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Reduction of leg edema 50%, [ Time Frame: 5 to 30 days ]
    10 cm below the patella on the operated leg three days post-operation in patients treated with impulsive compression in comparison to non-treated.

  2. Time to mobilization in pump treated patients [ Time Frame: 1 to 7 days ]
    Patient can get out of bed and go to the toilet.

  3. Length of stay in hospital [ Time Frame: 10 to 14 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192982


Contacts
Layout table for location contacts
Contact: Hans Ravn, MD PhD 004528718505 hans.ravn@rsyd.dk
Contact: Kim C Houlind, MD PhD 004576362403 kim.christian.houlind@rsyd.dk

Locations
Layout table for location information
Denmark
Hans Ravn Recruiting
Kolding, Denmark, 6000
Contact: Hans Ravn, MD. Ph.D    004528718505    hans.ravn@rsyd.dk   
Contact: Tenna Klit, MD       tenna.klit@rsyd.dk   
Principal Investigator: Kim Houlind, MD. Ph.D         
Sponsors and Collaborators
Kolding Sygehus
Investigators
Layout table for investigator information
Study Chair: Hans Ravn, MD PhD Vejle Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hans Ravn, Principal Investigator, Vejle Hospital
ClinicalTrials.gov Identifier: NCT03192982     History of Changes
Other Study ID Numbers: Impulsive compression i insitu
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Postoperative Complications
Pathologic Processes