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PREvention of Post-mastectomy LYMphoceles by PAdding (PRELYMCA)

Primary Purpose

Mastectomy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
classic closure
padding
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mastectomy focused on measuring padding, lymphoceles, prevention

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Female gender
  • Patients with infiltrating or in situ breast cancer
  • Indication of surgical treatment by mastectomy
  • Patient providing written informed consent
  • Patient with health insurance coverage
  • Ability to provide voluntary written informed consent

Exclusion Criteria:

  • Informed consent cannot be obtain
  • Pregnant or lactating women
  • Patients undergoing immediate breast reconstruction
  • Patients with cancer untreatable by mastectomy, non curative mastectomy: partial mastectomies, preventive mastectomies (BRCA genetic mutations)
  • Patients under legal protection or unable to come to a center
  • Patients unable to express voluntary consent
  • Patients receiving post operative anticoagulants or platelet antiaggregants
  • Patients requiring postoperative anticoagulants
  • Bilateral mastectomy

Sites / Locations

  • CHU AmiensRecruiting
  • CH CompiègneRecruiting
  • CH SoissonsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

classic closure

padding

Arm Description

mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration

areas of padding and stiching between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h.

Outcomes

Primary Outcome Measures

postoperative lymphoceles
presence or absence of postoperative lymphoceles

Secondary Outcome Measures

Full Information

First Posted
September 5, 2016
Last Updated
September 5, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02894021
Brief Title
PREvention of Post-mastectomy LYMphoceles by PAdding
Acronym
PRELYMCA
Official Title
PREvention of Post-mastectomy LYMphoceles by PAdding. A Randomized Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

Brief Summary
Lymphoceles, or seromas, are the most frequent complication following mastectomy and are associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as the presence of a palpable post operative serous accumulation that is bothersome for the patient and requires a puncture and drainage or even several repeated punctures. The presence of seromas is therefore associated with discomfort and pain. Seromas could also be responsible for increased morbidity due to complications such as infection, suture separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as obesity, increased post operative drainage of J1 to J3, and arterial hypertension. Different measures have demonstrated the benefits of limiting axillary lymphoceles after dissection : placement of a drain, padding and delay in shoulder mobility. Studies have shown that axillary padding decreases lymphocele development and shortens the length of hospital stay. Some studies based on padding of the mastectomy site also have shown a decrease in post operative seromas; however no study has been done on the usefulness of padding in the mastectomy site alone because they include both padding and a drain or padding of the axillary area. The padding technique the investigators employ is performed at the donor site in breast reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of seromas. In this study, the classic technique will be compared to padding in the mastectomy site with short drainage (48h).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy
Keywords
padding, lymphoceles, prevention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
classic closure
Arm Type
Active Comparator
Arm Description
mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration
Arm Title
padding
Arm Type
Experimental
Arm Description
areas of padding and stiching between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h.
Intervention Type
Procedure
Intervention Name(s)
classic closure
Intervention Description
mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration
Intervention Type
Procedure
Intervention Name(s)
padding
Intervention Description
areas of padding and running sutures between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h
Primary Outcome Measure Information:
Title
postoperative lymphoceles
Description
presence or absence of postoperative lymphoceles
Time Frame
Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Female gender Patients with infiltrating or in situ breast cancer Indication of surgical treatment by mastectomy Patient providing written informed consent Patient with health insurance coverage Ability to provide voluntary written informed consent Exclusion Criteria: Informed consent cannot be obtain Pregnant or lactating women Patients undergoing immediate breast reconstruction Patients with cancer untreatable by mastectomy, non curative mastectomy: partial mastectomies, preventive mastectomies (BRCA genetic mutations) Patients under legal protection or unable to come to a center Patients unable to express voluntary consent Patients receiving post operative anticoagulants or platelet antiaggregants Patients requiring postoperative anticoagulants Bilateral mastectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed AIT AMER MEZIANE, PhD
Phone
+33 3 22 66 85 23
Email
AitAmerMeziane.Mohamed@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed AIT AMER MEZIANE, PhD
Phone
+33 3 22 66 85 23
Email
AitAmerMeziane.Mohamed@chu-amiens.fr
Facility Name
CH Compiègne
City
Compiegne
ZIP/Postal Code
60321
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna MYCHALUK, MD
Facility Name
CH Soissons
City
Soissons
ZIP/Postal Code
02209
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal ABBOUD, MD

12. IPD Sharing Statement

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PREvention of Post-mastectomy LYMphoceles by PAdding

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