Post-operative Complication, Impulsive Compression, in Situ Bypass

NCT03192982 | Unknown

• 1 other identifier: Impulsive compression i insitu
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Compresion Therapy; Post-operative Edema; Wound Complication; Ischemia Limb; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Reduction of wound complications in the foot pump group

  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

  From randomization until 12 month examination (individual finish examination)

Secondary Outcomes (3)

• 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

Study Arms (2)

Foot pump (A-V Impulse, 6000 Series)

EXPERIMENTAL

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

Standard treatment (compression)

ACTIVE COMPARATOR

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)

Interventions

A-V impulse 6000 Series DEVICE

foot pad and pump

Foot pump (A-V Impulse, 6000 Series)

Standard treatment (compression) DEVICE

Short-stretch bandage from toes and up yo the upper thigh 40 mm Hg

Standard treatment (compression)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who need an insitu bypass from Common Femoral Artery to Popliteal AK/BK or crural Artery

You may not qualify if:

• 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-

Sponsors & Collaborators

• Kolding Sygehus: lead

Study Sites (1)

Hans Ravn

Kolding, 6000, Denmark

RECRUITING

Related Publications (1)

• Klit T, Dahl M, Houlind KC, Ravn H. Effect of Impulsive Compression Treatment on Postoperative Complications After Open Peripheral Vascular Revascularization (In Situ): Protocol for a Randomized Control Trial. JMIR Res Protoc. 2018 Feb 20;7(2):e58. doi: 10.2196/resprot.8799.

  PMID: 29463493 DERIVED

Study Officials

• Hans Ravn, MD PhD

  Vejle Hospital

  STUDY CHAIR

Central Study Contacts

Hans Ravn, MD PhD

CONTACT

004528718505; hans.ravn@rsyd.dk

Kim C Houlind, MD PhD

CONTACT

004576362403; kim.christian.houlind@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized prospective study

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 20, 2017
• Study Start: February 8, 2018
• Primary Completion: November 28, 2022
• Study Completion: November 30, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)