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Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage (QUISERMAS)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quilting suture without drainage
Conventional closure with drainage
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Mastectomy, Seroma, Quilting suture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ≥ 18 years and ≤ 85 years
  • Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
  • Women that give her informed written consent
  • French social security affiliation

Exclusion Criteria:

  • Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection.
  • Women with indication of bilateral mastectomy or immediate reconstruction.
  • Degenerative neuromuscular disease with thoracic muscular damage
  • Planned ambulatory surgery

Sites / Locations

  • Conception Hospital
  • Institut POALI-CALMETTES
  • Institut de Cancérologie de l'Ouest
  • CHU de Poitiers
  • Alliance Clinic
  • CHRU de Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Closure with conventional technique with drainage

Quilting suture without drainage

Arm Description

The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.

In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle.

Outcomes

Primary Outcome Measures

Wound seroma requiring aspiration or surgical intervention
A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles). Only grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.

Secondary Outcome Measures

Wound seroma requiring aspiration or surgical intervention
Wound seroma whatever their type (requiring or not intervention)
Wound seroma whatever their type (requiring or not intervention)
Other wound complications
Other wound complications
Surgical morbidity
Pain
Visual Analogue Scale
Homolateral shoulder movement
The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)
Cosmesis results
Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent
Health related quality of life : EQ-5D-5L
The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems
Cost-effectiveness assessment
Incremental net monetary benefice

Full Information

First Posted
September 29, 2014
Last Updated
October 19, 2018
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02263651
Brief Title
Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
Acronym
QUISERMAS
Official Title
Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.
Detailed Description
Eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection Randomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection). Two follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Mastectomy, Seroma, Quilting suture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closure with conventional technique with drainage
Arm Type
Active Comparator
Arm Description
The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.
Arm Title
Quilting suture without drainage
Arm Type
Experimental
Arm Description
In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle.
Intervention Type
Procedure
Intervention Name(s)
Quilting suture without drainage
Other Intervention Name(s)
Quilting suture
Intervention Description
In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced. Efficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex. The skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area.
Intervention Type
Procedure
Intervention Name(s)
Conventional closure with drainage
Other Intervention Name(s)
Conventional closure
Intervention Description
The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin. The skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent.
Primary Outcome Measure Information:
Title
Wound seroma requiring aspiration or surgical intervention
Description
A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles). Only grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.
Time Frame
Within 21 days following mastectomy
Secondary Outcome Measure Information:
Title
Wound seroma requiring aspiration or surgical intervention
Time Frame
Within 9 months following mastectomy
Title
Wound seroma whatever their type (requiring or not intervention)
Time Frame
Within 21 days following mastectomy
Title
Wound seroma whatever their type (requiring or not intervention)
Time Frame
Within 9 months following mastectomy
Title
Other wound complications
Time Frame
Within 21 days following mastectomy
Title
Other wound complications
Time Frame
Within 9 months following mastectomy
Title
Surgical morbidity
Time Frame
During surgical intervention
Title
Pain
Description
Visual Analogue Scale
Time Frame
Before surgery, day 1, 21 days and 9 months following mastectomy
Title
Homolateral shoulder movement
Description
The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)
Time Frame
Before surgery, 21 days and 9 months following mastectomy
Title
Cosmesis results
Description
Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent
Time Frame
21 days, 9 months following mastectomy
Title
Health related quality of life : EQ-5D-5L
Description
The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems
Time Frame
Before surgery, day 1, 21 days and 9 months following mastectomy
Title
Cost-effectiveness assessment
Description
Incremental net monetary benefice
Time Frame
During the whole follow-up period i.e. 9 months following mastectomy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≥ 18 years and ≤ 85 years Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection Women that give her informed written consent French social security affiliation Exclusion Criteria: Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection. Women with indication of bilateral mastectomy or immediate reconstruction. Degenerative neuromuscular disease with thoracic muscular damage Planned ambulatory surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lobna OULDAMER, MD
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Conception Hospital
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Institut POALI-CALMETTES
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Name
Alliance Clinic
City
St Cyr sur Loire
Country
France
Facility Name
CHRU de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27044574
Citation
Ouldamer L, Bonastre J, Brunet-Houdard S, Body G, Giraudeau B, Caille A. Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 4;6(4):e009903. doi: 10.1136/bmjopen-2015-009903.
Results Reference
derived

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Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

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