Quilting Sutures After Mastectomy (BE-Quilt)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Mastectomy with Quilting sutures without drain placement; Procedure: Mastectomy with Conventional sutures with drain placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06415032

S66948

Details and patient eligibility

About

The use of wound drains after mastectomy is common practice in Belgium. However, placement of suction drainage has several disadvantages. Skin bacteria can enter via the drain and cause infection, or the drain itself can cause discomfort and a need for daily nursing. After drain removal, seroma is the most common complication following breast cancer surgery. Seromas are collections of serous fluid that frequently develop under the skin or in the axillary space formed after mastectomy and/or axillary lymph node dissection, resulting from surgical trauma to blood/lymphatic vessels and post-traumatic inflammation. Seroma formation can cause discomfort and limitations in shoulder function. Moreover, it is associated with surgical site infections, often requires treatment and increases healthcare consumption. Wound healing problems might be a cause of postponement of adjuvant therapy.

The quilting suture technique, in which the skin is sutured to the pectoralis muscle and drain placement is not needed, may lead to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections.

In this national multicentric study, we will compare mastectomy with placement of suction drains, a standard technique used in the vast majority of Belgian hospitals, with the new quilting suture technique without placement of suction drains. We will focus on 3 distinct primary outcomes:

• Pain of the mastectomy area 6 months after surgery
• Upper limb function 6 months after surgery
• Cosmetic outcome scored by the patient 6 months after surgery.

The goal of this study is to demonstrate the absence of long-term negative effects of the quilting suture technique on shoulder function, cosmetic outcome, and pain management.

Enrollment: 296 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• capable of giving written informed consent
• age ≥ 18 years
• scheduled for unilateral mastectomy without immediate breast reconstruction with or without axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)

Exclusion criteria

• scheduled for mastectomy with immediate breast reconstruction
• scheduled for synchronous bilateral breast and/or axillary surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Quilting sutures without drain placement

Experimental group

Treatment:

Procedure: Mastectomy with Quilting sutures without drain placement

Conventional sutures with drain placement

Active Comparator group

Treatment:

Procedure: Mastectomy with Conventional sutures with drain placement