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Inelastic Compression in Edema After Revascularization (COMPRIME)

C

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Lymphedema

Treatments

Device: Inelastic compression

Study type

Interventional

Funder types

Other

Identifiers

NCT05910411
2022-A02260-43 (Registry Identifier)
22-AOIP-02

Details and patient eligibility

About

The appearance of revascularization edema of the lower limb is a frequent complication in peripheral vascular surgery. It can lead to a delay in healing and even to trophic disorders.

The prevention and treatment of this complication have so far been limited to postural measures (elevation of the limbs), in the absence of other recommendations and given the contraindication of elastic compression.

Inelastic compression is another mode of compression sometimes used in the treatment of lymphedema. It exerts a stable continuous pressure regardless of the patient's position. The investigator's aim is to demonstrate that compression with inelastic bands, applied under good conditions, does not have a major effect on distal arterial vascularization in arterial patients who have undergone revascularization by supra-articular bypass or endovascular treatment of the lower limb.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. patients over 18 years of age
  2. arteriopathic patients requiring femoropopliteal revascularization by bypass surgery who have been revascularized
  3. signature of an informed consent
  4. person affiliated or beneficiary of a social security plan

Exclusion criteria

  1. arterial bypasses under the leg or distal joints
  2. critical ischemia
  3. patients operated on for acute ischemia
  4. pregnant or breast-feeding women
  5. severe cardiac insufficiency
  1. severe peripheral neuropathy 6) allergies to the components of the tapes 7) persons deprived of liberty by judicial or administrative decision 8) persons under legal protection

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Inelastic compression
Experimental group
Description:
Inelastic compression used in the treatment of lymphedema
Treatment:
Device: Inelastic compression

Trial contacts and locations

1

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Central trial contact

PASCAL GIORDANA

Data sourced from clinicaltrials.gov

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