Local Compression Seroma DIminution Objective (CLODIS) (CLODIS)

Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Seroma; Mastectomy
• Intervention / Treatment: Device: Compression by chest bandage urgo K2®; Procedure: punctures

Detailed Description

The most common complication induced by mastectomy is seroma formation. This seroma is a serolymphatic effusion that is created in the days following surgery. Iterative puncture is the only treatment for seroma mentioned in the literature. A retrospective study in the investigator's establishment on 1800 patients determined that a second puncture greater than 250ml is predictive of a chronicisation of punctures. The research hypothesis is that by applying local compression by chest bandaging with the Urgo® K2 kit, the "dead space" created by surgery would be removed. This would help resorb the seroma and reduce the number of punctures.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JULIE TANQUREL, NURSE; Phone Number: 33231455631; Email: j.tanquerel@baclesse.unicancer.fr
• Study Contact Backup: Name: FRANCOIS GERNIER, PROJECT MANAGER; Phone Number: 33231454043; Email: f.gernier@baclesse.unicancer.fr

Study Locations

• France
  • Caen, France, 14400
    • Recruiting
    • TANQUEREL Julie
    • Contact: JULIE TANQUEREL, NURSE; Phone Number: 33 2 31 45 5631; Email: j.tanquerel@baclesse.unicancer.fr
    • Contact: FRANCOIS GERNIER, PROJECT MANAGER; Phone Number: 33 2 31 45 4043; Email: f.gernier@baclesse.unicancer.fr
    • Principal Investigator: JEAN-FRANCOIS LEBRUN, MD
  • Caen, France
    • Recruiting
    • Centre Françis Baclesse
    • Contact: Jean-François LEBRUN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Mastectomy with immediate reconstruction.
• Partial mastectomy.
• Concurrent bilateral mastectomy.
• Delay in healing observed at inclusion.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compression by chest bandage urgo K2®; 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®; - Installation of a short stretch belt (urgo K2® kit); - Installation of a long stretch cohesive band providing additional pressure necessary to reach therapeutic pressure and maintain the device (urgo K2® kit).; - 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.
Active Comparator: punctures; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time required to take charge of adjuvant treatments	Deferral of adjuvant therapy related to seroma: Treatment regimen and adjuvant appointments will be collected at inclusion. Each deviation will be analyzed and attributed or not to the presence or complications of seroma.	180 days
Volume punctured after inclusion in both patient groups.	For each new puncture, the volume of serolymphatic fluid will be measured and the time between two punctures analyzed	180 days
comparison of the average change Quality of life scores between each arm	Quality of life is assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer (study inclusion and exit). The EORTC QLQ-C30 questionnaire, resulting in a score for the quality of life between 0 to 100.	180 days
comparison of the average change anxiety scores between each arm	Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale (study inclusion and exit)	180 days
comparison of the average change Pain scores between each arm	Numerical rating scale for pain (EN) The EN evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation", 3 "pain threshold", 10 "pain as bad as could be.(at each visit),; Neuropathic Pain (DN4) (inclusion and study exit)	180 days
The aesthetic impact on the puncture site.	The evaluation of the aesthetic impact on the puncture zone will be carried out by comparing the photographs taken at the inclusion, during the visit to the consultation at 10-15 days after the last puncture (for the standard arm) and at 10-15 days after the removal of the bandage device and finally during the consultation with the oncologist.	180 days
Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture	Based on the observation grids carried out by the 2 professionals during a separate evaluation, we compare the 4 items defined to the indication chosen for the puncture as well as the volume of puncture when it is carried out.	180 days

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2018
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: CLODIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No