Breast CancerPhase 3CLODISNCT03598712
Local Compression Seroma DIminution Objective (CLODIS)
A Phase 3 study testing Compression by chest bandage urgo K2® and punctures in people with Breast Cancer and Mastectomy, run by Centre Francois Baclesse at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Seroma
- What is being tested?
- Compression by chest bandage urgo K2® and punctures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Nov 2018to 30 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mastectomy with immediate reconstruction.
- Partial mastectomy.
- Concurrent bilateral mastectomy.
- Delay in healing observed at inclusion.
- Patient under legal protection.
- Chronic respiratory failure.
Show all 9Show fewer
- Patient with a pacemaker.
- Personality disorders and known progressive psychiatric pathology.
- Inability to submit to trial follow-up
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Compression by chest bandage urgo K2®, punctures
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression by chest bandage urgo K2®Device
- - 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
puncturesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Compression by chest bandage urgo K2® | Experimental | 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. Receives: Device: Compression by chest bandage urgo K2®; Procedure: punctures |
| punctures | Active comparator | 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. Receives: Procedure: punctures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 180 days
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start18 Nov 2018
- Primary completion18 Apr 2020
- Study completion30 Aug 2020
Why it stopped: Surgical practices have evolved as surgeons practice immediate reconstructive surgery. We have not been able to meet the recruitment target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3 prospective, randomized, monocentric controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598712
- Sponsor's protocol ID
- CLODIS
- Acronym
- CLODIS
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2018
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03598712
- Acronym / sponsor ID
- CLODIS / CLODIS
- Conditions
- Breast Cancer, Mastectomy, Seroma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgical practices have evolved as surgeons practice immediate reconstructive surgery. We have not been able to meet the recruitment target.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 3 prospective, randomized, monocentric controlled study
| Arm | Type | Receives |
|---|---|---|
| Compression by chest bandage urgo K2® | Experimental | Device: Compression by chest bandage urgo K2®, Procedure: puncturesAfter 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. |
| punctures | Active comparator | Procedure: puncturesAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Mastectomy with immediate reconstruction.
- Partial mastectomy.
- Concurrent bilateral mastectomy.
- Delay in healing observed at inclusion.
- Patient under legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Compression by chest bandage urgo K2® |
| puncturesEvery 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. | Procedure or surgery | Compression by chest bandage urgo K2®, punctures |
Primary outcome
Number of puncture(s) after inclusion in both patient groups
Time frame: 180 days
In each group, we will count the number of punctures performed after the 2nd puncture with a volume > 250ml (inclusion).
7 secondary outcomes
The time required to take charge of adjuvant treatments
Time frame: 180 days
Volume punctured after inclusion in both patient groups.
Time frame: 180 days
comparison of the average change Quality of life scores between each arm
Time frame: 180 days
comparison of the average change anxiety scores between each arm
Time frame: 180 days
comparison of the average change Pain scores between each arm
Time frame: 180 days
The aesthetic impact on the puncture site.
Time frame: 180 days
Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture
Time frame: 180 days
Results and safety
The study was stopped early (reason given: Surgical practices have evolved as surgeons practice immediate reconstructive surgery. We have not been able to meet the recruitment target.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Compression by chest bandage urgo K2® and punctures in people with Breast Cancer and Mastectomy, run by Centre Francois Baclesse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Surgical practices have evolved as surgeons practice immediate reconstructive surgery. We have not been able to meet the recruitment target.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture(s) after inclusion in both patient groups (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.