NCT03598712

Local Compression Seroma DIminution Objective (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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Mastectomy
• Seroma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-18
• Primary completion: 2020-04-18
• Completion: 2020-08-30
• First posted: 2018-07-26
• Last updated: 2025-10-06

Locations

2 sites across 1 country: France