Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
- Conditions
- Breast Cancer
- Interventions
- Procedure: Conventional closure with drainageProcedure: Quilting suture without drainage
- Registration Number
- NCT02263651
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 320
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Closure with conventional technique with drainage 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. Quilting suture without drainage 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.
- Primary Outcome Measures
Name Time Method Wound seroma requiring aspiration or surgical intervention 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
Name Time Method Wound seroma whatever their type (requiring or not intervention) Within 9 months following mastectomy Other wound complications Within 9 months following mastectomy Surgical morbidity During surgical intervention Pain Before surgery, day 1, 21 days and 9 months following mastectomy Visual Analogue Scale
Wound seroma requiring aspiration or surgical intervention Within 9 months following mastectomy Homolateral shoulder movement 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°)
Cosmesis results 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
Health related quality of life : EQ-5D-5L 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
Cost-effectiveness assessment During the whole follow-up period i.e. 9 months following mastectomy Incremental net monetary benefice
Trial Locations
- Locations (6)
Conception Hospital
🇫🇷Marseille, France
CHRU de Tours
🇫🇷Tours, France
Alliance Clinic
🇫🇷St Cyr sur Loire, France
Institut de Cancérologie de l'Ouest
🇫🇷Nantes, France
CHU de Poitiers
🇫🇷Poitiers, France
Institut POALI-CALMETTES
🇫🇷Marseille, France