Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

Breast Cancer Clinical Trial

— QUISERMAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263651
• Other study ID #: PHRCK13 - LO / QUISERMAS
• Secondary ID: 2014-A00901-4614
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Conception Hospital	Marseille
France	Institut POALI-CALMETTES	Marseille
France	Institut de Cancérologie de l'Ouest	Nantes
France	CHU de Poitiers	Poitiers
France	Alliance Clinic	St Cyr sur Loire
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound seroma requiring aspiration or surgical intervention		Within 9 months following mastectomy
Secondary	Wound seroma whatever their type (requiring or not intervention)		Within 21 days following mastectomy
Secondary	Wound seroma whatever their type (requiring or not intervention)		Within 9 months following mastectomy
Secondary	Other wound complications		Within 21 days following mastectomy
Secondary	Other wound complications		Within 9 months following mastectomy
Secondary	Surgical morbidity		During surgical intervention
Secondary	Pain	Visual Analogue Scale	Before surgery, day 1, 21 days and 9 months following mastectomy
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost-effectiveness assessment	Incremental net monetary benefice	During the whole follow-up period i.e. 9 months following mastectomy