Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
ConditionLymphocele
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years old,
Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
Affiliated with a health insurance plan
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Bandage
DeviceBandage
No bandage
DeviceNo bandage
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: drain + compression bandageExperimental treatment 1 intervention
Group B: drain without compression bandageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
6 monthsSecondary outcomes
1
Lymphocele volume in milliliter
Lymphocele volume at day 4, day 8 and 6 months post mastectomy
Time frame
6 months2
Number of lymphocele punctures
Number of lymphocele punctures possibly performed during the 6 months of follow-up
Time frame
6 months3
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).
Time frame
8 days4
Frequency of adverse events
The frequency of adverse events during the 6-month follow-up
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov