Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage (QUISERMAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Conventional closure with drainage; Procedure: Quilting suture without drainage

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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Conception hospital
  • Marseille, France, 13009
    • Institut POALI-CALMETTES
  • Nantes, France
    • Institut de Cancérologie de l'Ouest
  • Poitiers, France
    • CHU de Poitiers
  • St Cyr sur Loire, France
    • Alliance Clinic
  • Tours, France
    • CHRU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Closure with conventional technique 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.	Procedure: 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.; Other Names: Conventional closure
Experimental: 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.	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.; Other Names: Quilting suture

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Lobna OULDAMER, MD, University Hospital, Tours

Publications and helpful links

General Publications

• Ouldamer L, Bonastre J, Brunet-Houdard S, Body G, Giraudeau B, Caille A. Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 4;6(4):e009903. doi: 10.1136/bmjopen-2015-009903.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Breast cancer; Mastectomy; Seroma; Quilting suture
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PHRCK13 - LO / QUISERMAS; 2014-A00901-46 (Other Identifier: ID RCB); 140730B-12 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided