A Phase 3 interventional study of Compression by chest bandage urgo K2® and punctures in Breast Cancer, Mastectomy and Seroma, sponsored by Centre Francois Baclesse. Terminated at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Centre Francois Baclesse · Phase 3, Interventional, and Treatment
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Francois Baclesse is the lead sponsor of 110 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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).
Time frame: 180 days
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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 180 days
comparison of the average change Pain scores between each arm
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)
Time frame: 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.
Time frame: 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.
Time frame: 180 days
Plan to share: No
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This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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