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Completed

NCT Number: NCT02263651

Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Seroma Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Conception Hospital, Marseille, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quilting suture without drainage

Procedure

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 names: Quilting suture

Conventional closure with drainage

Procedure

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 names: Conventional closure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: QUISERMAS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2014
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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