Local Compression Seroma DIminution Objective (CLODIS)

NCT03598712 | Terminated Phase 3 DMC

• 1 other identifier: CLODIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer; Mastectomy; Seroma

Outcome Measures

Primary Outcomes (1)

• Number of puncture(s) after inclusion in both patient groups

  In each group, we will count the number of punctures performed after the 2nd puncture with a volume \> 250ml (inclusion).

  180 days

Secondary Outcomes (7)

• The time required to take charge of adjuvant treatments

  180 days

• Volume punctured after inclusion in both patient groups.

  180 days

• comparison of the average change Quality of life scores between each arm

  180 days

• comparison of the average change anxiety scores between each arm

  180 days

• comparison of the average change Pain scores between each arm

  180 days

Study Arms (2)

Compression by chest bandage urgo K2®

EXPERIMENTAL

After the second puncture, the local compression by thoracic bandage will be put in place. The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out. During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit. The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.

Device: Compression by chest bandage urgo K2®; Procedure: punctures

punctures

ACTIVE COMPARATOR

After the second puncture, the patient will be seen at the same frequency as in the experimental arm. The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.

Procedure: punctures

Interventions

Compression by chest bandage urgo K2® DEVICE

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

Compression by chest bandage urgo K2®

punctures PROCEDURE

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.

Compression by chest bandage urgo K2®; punctures

Eligibility Criteria

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

You may qualify if:

• Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing.
• Patient with a second seroma puncture with a volume greater than or equal to 250 ml.
• Neo adjuvant chemotherapy authorized.
• Absence of known metastases.
• Patient has given written consent.

You may not qualify if:

• Mastectomy with immediate reconstruction.
• Partial mastectomy.
• Concurrent bilateral mastectomy.
• Patient under legal protection.
• Chronic respiratory failure.
• Patient with a pacemaker.
• Personality disorders and known progressive psychiatric pathology.
• Inability to submit to trial follow-up

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (2)

TANQUEREL Julie

Caen, 14400, France

Location

Centre Françis Baclesse

Caen, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Punctures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 3 prospective, randomized, monocentric controlled study

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 26, 2018
• Study Start: November 18, 2018
• Primary Completion: April 18, 2020
• Study Completion: August 30, 2020
• Last Updated: October 6, 2025

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)