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Local Compression Seroma DIminution Objective (CLODIS)

NCT03598712 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-06

No results posted yet for this study

Summary

This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.

Conditions

Interventions

DEVICE

Compression by chest bandage urgo K2®

1. \- Installation of a short stretch belt (urgo K2® kit) 2. \- Installation of a long stretch cohesive band providing additional pressure necessary to reach therapeutic pressure and maintain the device (urgo K2® kit). 3. \- Control of the pressure exerted by the bandage by the "KIKUHIME® Sub Bandge pressure Monitor" device

PROCEDURE

punctures

Every 7 days after the second puncture of a volume \> 250ml of seroma, the patients are examined by 2 practitioners. They define the indication of the puncture. The seroma is aspirated after a skin puncture with a needle connected with a Redon® drain.

Sponsors & Collaborators

  • Centre Francois Baclesse

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-18
Primary Completion
2020-04-18
Completion
2020-08-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598712 on ClinicalTrials.gov