LymphoceleBANDOCELENCT04819542
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
A study testing Bandage and No bandage in people with Lymphocele, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphocele
- What is being tested?
- Bandage and No bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2021to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients over 18 years old,
- Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
- Affiliated with a health insurance plan
Who cannot join
- Recurrence of breast cancer,
- Mastectomy with RMI (immediate breast reconstruction) at the same time of operation
- Anticoagulant treatment at curative dose
- Arteritis obliterans of the upper limbs,
- Other cancer during treatment,
- Decompensated heart failure,
Show all 18Show fewer
- Acute infectious episode (cellulitis, erysipelas, lymphangitis)
- Acute deep vein thrombosis upper limb ipsilateral to mastectomy,
- Cutaneous atrophy of the upper limb,
- Bullous dermatoses,
- Hyperalgesia of the shoulder
- Inability to submit to the constraints of the protocol,
- Impossibility for the patient to achieve self-restraint at the thoracic level
- Pregnancy,
- Feeding with milk
- BMI> 35
- Adult protected by law (guardianship, curatorship and safeguard of justice).
- Anyone who is not in a position to give their consent in writing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital
Toulouse, 31059
Julie MALLOIZEL, MD, malloizel.j@chu-toulouse.fr
About this study
Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery.
This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer.
Read more
There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences.
This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.
- Conditions
- Lymphocele
- Being tested
- Bandage, No bandage
- Keywords
- mastectomy
- Medical subject headings
- Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BandageDevice
Bandage
No bandageDevice
No bandage
| Study group | Role | What they receive |
|---|---|---|
| drain + compression bandage | Experimental | Not described Receives: Device: Bandage |
| drain without compression bandage | Active comparator | Not described Receives: Device: No bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion in percentage of patients treated successfully
Provide an estimate of the proportion of patients treated successfully (success rate defined by the absence of lymphocele on D4 post mastectomy) in two groups of patients (drain + compression bandage vs drain without compression bandage).
Measured: 6 months
Secondary outcomes (8)
Lymphocele volume in milliliter
Lymphocele volume at day 4, day 8 and 6 months post mastectomy
Measured: 6 months
Number of lymphocele punctures
Number of lymphocele punctures possibly performed during the 6 months of follow-up
Measured: 6 months
Clinical signs associated with lymphocele
Clinical signs associated with lymphocele at day 4 and day 8 (redness, blister, local inflammation (erythema + redness + warmth), rash, pruritus, ecchymosis, wound, allergic reaction, presence of clinical lymphocele, pain in the limb ipsilateral on surgery, heaviness in the ipsilateral limb discomfort when using the ipsilateral limb, perimeter measurements (in centimeters) at the level of both upper limbs using a standard seamstress ruler, measurement of joint amplitudes (in centimeters).
Measured: 8 days
Frequency of adverse events
The frequency of adverse events during the 6-month follow-up
Measured: 6 months
Clinical signs associated with lymphocele
Clinical signs associated with lymphocele at day 4 and day 8 : perimeter measurements (in centimeters) at the level of both upper limbs using a standard seamstress ruler
Measured: 8 days
Clinical signs associated with lymphocele
Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).
Measured: 8 days
Changes in quality of life
Changes in quality of life, with QLQ-C30 questionnaire, (specifically linked to breast cancer and overall quality of life) at day 8, day 21 and at 6 months post mastectomy, compared to an assessment before mastectomy
Measured: 6 months
Changes in quality of life
Changes in quality of life, with 5Q-5D-5L questionnaire, (specifically linked to breast cancer and overall quality of life) at day 8, day 21 and at 6 months post mastectomy, compared to an assessment before mastectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start16 Aug 2021
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphoceleStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie MALLOIZEL DELAUNAY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819542
- Sponsor's protocol ID
- RC31/17/0350
- Acronym
- BANDOCELE
- Status last verified
- May 2026
- First submitted
- 17 Mar 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
- ClinicalTrials.gov ID
- NCT04819542
- Acronym / sponsor ID
- BANDOCELE / RC31/17/0350
- Conditions
- Lymphocele
- Keywords
- mastectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 Mar 2021 (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.
Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery.
This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer.
There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences.
This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drain + compression bandage | Experimental | Device: Bandage |
| drain without compression bandage | Active comparator | Device: No bandage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old,
- Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
- Affiliated with a health insurance plan
Key exclusion criteria (18 listed)
- Recurrence of breast cancer,
- Mastectomy with RMI (immediate breast reconstruction) at the same time of operation
- Anticoagulant treatment at curative dose
- Arteritis obliterans of the upper limbs,
- Other cancer during treatment,
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 |
|---|---|---|
| BandageBandage | Device | drain + compression bandage |
| No bandageNo bandage | Device | drain without compression bandage |
Primary outcome
Proportion in percentage of patients treated successfully
Time frame: 6 months
Provide an estimate of the proportion of patients treated successfully (success rate defined by the absence of lymphocele on D4 post mastectomy) in two groups of patients (drain + compression bandage vs drain without compression bandage).
8 secondary outcomes
Lymphocele volume in milliliter
Time frame: 6 months
Number of lymphocele punctures
Time frame: 6 months
Clinical signs associated with lymphocele
Time frame: 8 days
Frequency of adverse events
Time frame: 6 months
Clinical signs associated with lymphocele
Time frame: 8 days
Clinical signs associated with lymphocele
Time frame: 8 days
Changes in quality of life
Time frame: 6 months
Changes in quality of life
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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.
Julie MALLOIZEL DELAUNAY, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bandage and No bandage in people with Lymphocele, run by University Hospital, Toulouse at 1 site 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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie MALLOIZEL DELAUNAY, MD (5 61 32 30 33 ext. +33, malloizel-delaunay.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion in percentage of patients treated successfully (time frame: 6 months). 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 1 Jun 2026.