Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Quilting suture without drainage
* Procedure: Conventional closure with drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closure with conventional technique with drainage<br>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<br>* 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.<br>* Other names: Conventional closure;|
| Experimental: Quilting suture without drainage<br>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<br>* 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.<br>* Other names: Quilting suture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 21 days following mastectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound seroma requiring aspiration or surgical intervention |  | Within 9 months following mastectomy | 
| Wound seroma whatever their type (requiring or not intervention) |  | Within 21 days following mastectomy | 
| Wound seroma whatever their type (requiring or not intervention) |  | Within 9 months following mastectomy | 
| Other wound complications |  | Within 21 days following mastectomy | 
| Other wound complications |  | Within 9 months following mastectomy | 
| Surgical morbidity |  | During surgical intervention | 
| Pain | Visual Analogue Scale | Before surgery, day 1, 21 days and 9 months following mastectomy | 
| 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°) | Before surgery, 21 days and 9 months following mastectomy | 
| Cosmesis results | Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent | 21 days, 9 months following mastectomy | 
| 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 | Before surgery, day 1, 21 days and 9 months following mastectomy | 
| Cost-effectiveness assessment | Incremental net monetary benefice | During the whole follow-up period i.e. 9 months following mastectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Mastectomy, Seroma, Quilting suture