Quilting Sutures After Mastectomy

Официальное название

Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial

Обзор

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.

Вмешательства

• Процедура Mastectomy with Quilting sutures without drain placement
  The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After the mastectomy, the skin flaps are sutured onto the pectoral muscle using polyfilament absorbable sutures (e.g. Stratafix PDS® 1 CT needle) placed at 4- to 5-cm intervals in two or three rows depending on the extent of the skin flaps. Care is taken to prevent dimpling of the skin. The axillary region i
• Процедура Mastectomy with Conventional sutures with drain placement
  The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After mastectomy no flap fixation is performed. The skin is closed in a conventional manner using an absorbable skin suture. One or two suction drains are placed before skin closure. The drains are placed in the mastectomy gutter lateral to the pectoral muscle and/or in the prepectoral area. For skin closure

Первичные конечные точки

• Pain in the mastectomy area scored by VAS [Срок оценки: 6 months postoperative]
• Upper limb function scored by QuickDASH [Срок оценки: 6 months postoperative]
• Cosmetic outcome scored by the patient on a 10-point scale [Срок оценки: 6 months postoperative]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Surgical Oncology, UZ Leuven — Leuven

Идентификаторы

NCT: NCT06415032 · S66948

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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