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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Quilting suture without drainage; Procedure: Conventional closure with drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT02263651

140730B-12 (Other Identifier)

PHRCK13 - LO / QUISERMAS

2014-A00901-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Closure with conventional technique with drainage

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional closure with drainage

Quilting suture without drainage

Experimental group

Description:

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.

Treatment:

Procedure: Quilting suture without drainage