An interventional study of Quilting suture without drainage and Conventional closure with drainage in Breast Cancer, sponsored by University Hospital, Tours. Completed at 6 sites in France. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-10-22.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Prevention
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 320 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
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
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.
Also known as: Quilting suture
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.
Also known as: Conventional closure
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.
Time frame: Within 21 days following mastectomy
Wound seroma requiring aspiration or surgical intervention
Time frame: Within 9 months following mastectomy
Wound seroma whatever their type (requiring or not intervention)
Time frame: Within 21 days following mastectomy
Wound seroma whatever their type (requiring or not intervention)
Time frame: Within 9 months following mastectomy
Other wound complications
Time frame: Within 21 days following mastectomy
Other wound complications
Time frame: Within 9 months following mastectomy
Surgical morbidity
Time frame: During surgical intervention
Pain
Visual Analogue Scale
Time frame: 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°)
Time frame: 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
Time frame: 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
Time frame: Before surgery, day 1, 21 days and 9 months following mastectomy
Cost-effectiveness assessment
Incremental net monetary benefice
Time frame: During the whole follow-up period i.e. 9 months following mastectomy
Plan to share: Undecided
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Tours