Local Compression Seroma DIminution Objective (CLODIS)

Breast Cancer Clinical Trial

— CLODIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598712
• Other study ID #: CLODIS
• Status: Recruiting
• Phase: Phase 3
• Start date: November 18, 2018
• Est. completion date: October 2020

Study information

• Verified date: July 2019
• Source: Centre Francois Baclesse
• Contact: JULIE TANQUREL, NURSE
• Phone: 33231455631
• Email: j.tanquerel[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Mastectomy
• Seroma

Intervention

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.

Locations

Country	Name	City	State
France	Centre Françis Baclesse	Caen
France	TANQUEREL Julie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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