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

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ClinicalTrials.gov Identifier: NCT02263651
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Quilting suture without drainage Procedure: Conventional closure with drainage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Closure with conventional technique with drainage
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.
Procedure: Conventional closure with drainage

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.

Other Name: Conventional closure

Experimental: Quilting suture without drainage
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.
Procedure: Quilting suture without drainage

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.

Other Name: Quilting suture




Primary Outcome Measures :
  1. Wound seroma requiring aspiration or surgical intervention [ Time Frame: Within 21 days following mastectomy ]

    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 :
  1. Wound seroma requiring aspiration or surgical intervention [ Time Frame: Within 9 months following mastectomy ]
  2. Wound seroma whatever their type (requiring or not intervention) [ Time Frame: Within 21 days following mastectomy ]
  3. Wound seroma whatever their type (requiring or not intervention) [ Time Frame: Within 9 months following mastectomy ]
  4. Other wound complications [ Time Frame: Within 21 days following mastectomy ]
  5. Other wound complications [ Time Frame: Within 9 months following mastectomy ]
  6. Surgical morbidity [ Time Frame: During surgical intervention ]
  7. Pain [ Time Frame: Before surgery, day 1, 21 days and 9 months following mastectomy ]
    Visual Analogue Scale

  8. Homolateral shoulder movement [ Time Frame: Before surgery, 21 days and 9 months following mastectomy ]
    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°)

  9. Cosmesis results [ Time Frame: 21 days, 9 months following mastectomy ]
    Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent

  10. Health related quality of life : EQ-5D-5L [ Time Frame: Before surgery, day 1, 21 days and 9 months following mastectomy ]
    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

  11. Cost-effectiveness assessment [ Time Frame: During the whole follow-up period i.e. 9 months following mastectomy ]
    Incremental net monetary benefice



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263651


Locations
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France
Conception Hospital
Marseille, France, 13005
Institut POALI-CALMETTES
Marseille, France, 13009
Institut de Cancérologie de l'Ouest
Nantes, France
CHU de Poitiers
Poitiers, France
Alliance Clinic
St Cyr sur Loire, France
CHRU de Tours
Tours, France
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Lobna OULDAMER, MD University Hospital, Tours
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02263651    
Other Study ID Numbers: PHRCK13 - LO / QUISERMAS
2014-A00901-46 ( Other Identifier: ID RCB )
140730B-12 ( Other Identifier: ANSM )
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Tours:
Breast cancer
Mastectomy
Seroma
Quilting suture
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases