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Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles (BANDOCELE)

Primary Purpose

Lymphocele

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bandage
No bandage
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphocele focused on measuring mastectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years old,
  • Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
  • Affiliated with a health insurance plan

Exclusion Criteria:

  • 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,
  • 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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

drain + compression bandage

drain without compression bandage

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Lymphocele volume in milliliter
Lymphocele volume at day 4, day 8 and 6 months post mastectomy
Number of lymphocele punctures
Number of lymphocele punctures possibly performed during the 6 months of follow-up
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).
Frequency of adverse events
The frequency of adverse events during the 6-month follow-up
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
Clinical signs associated with lymphocele
Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).
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
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

Full Information

First Posted
March 17, 2021
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04819542
Brief Title
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Acronym
BANDOCELE
Official Title
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocele
Keywords
mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drain + compression bandage
Arm Type
Experimental
Arm Title
drain without compression bandage
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bandage
Intervention Description
Bandage
Intervention Type
Device
Intervention Name(s)
No bandage
Intervention Description
No bandage
Primary Outcome Measure Information:
Title
Proportion in percentage of patients treated successfully
Description
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 months
Secondary Outcome Measure Information:
Title
Lymphocele volume in milliliter
Description
Lymphocele volume at day 4, day 8 and 6 months post mastectomy
Time Frame
6 months
Title
Number of lymphocele punctures
Description
Number of lymphocele punctures possibly performed during the 6 months of follow-up
Time Frame
6 months
Title
Clinical signs associated with lymphocele
Description
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 days
Title
Frequency of adverse events
Description
The frequency of adverse events during the 6-month follow-up
Time Frame
6 months
Title
Clinical signs associated with lymphocele
Description
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
Time Frame
8 days
Title
Clinical signs associated with lymphocele
Description
Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).
Time Frame
8 days
Title
Changes in quality of life
Description
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
Time Frame
6 months
Title
Changes in quality of life
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years old, Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer Affiliated with a health insurance plan Exclusion Criteria: 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie MALLOIZEL DELAUNAY, MD
Phone
5 61 32 30 33
Ext
+33
Email
malloizel-delaunay.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte VAYSSE
Phone
5 31 15 53 84
Ext
+33
Email
vaysse.c@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie MALLOIZEL DELAUNAY, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie MALLOIZEL, MD
Email
malloizel.j@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles

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