Local Compression Seroma DIminution Objective (CLODIS)

Phase 3

• Conditions: Breast Cancer; Mastectomy; Seroma
• Interventions: Procedure: punctures; Device: Compression by chest bandage urgo K2®

• Registration Number: NCT03598712
• Lead Sponsor: Centre Francois Baclesse

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.

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 Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-11-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15
• Primary Completion: 2020-04
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
punctures	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.
Compression by chest bandage urgo K2®	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.
Compression by chest bandage urgo K2®	punctures	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.

Primary Outcome Measures

Name	Time	Method
Number of puncture(s) after inclusion in both patient groups	180 days	In each group, we will count the number of punctures performed after the 2nd puncture with a volume \> 250ml (inclusion).

Secondary Outcome Measures

Name	Time	Method
The time required to take charge of adjuvant treatments	180 days	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.
comparison of the average change Quality of life scores between each arm	180 days	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.
comparison of the average change Pain scores between each arm	180 days	1. 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),; 2. Neuropathic Pain (DN4) (inclusion and study exit)
comparison of the average change anxiety scores between each arm	180 days	Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale (study inclusion and exit)
Volume punctured after inclusion in both patient groups.	180 days	For each new puncture, the volume of serolymphatic fluid will be measured and the time between two punctures analyzed
The aesthetic impact on the puncture site.	180 days	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.
Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture	180 days	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.

Trial Locations

Locations (2)

TANQUEREL Julie; 🇫🇷 Caen, France

Centre Françis Baclesse; 🇫🇷 Caen, France