Clinical trial NCT06415032: Quilting Sutures After Mastectomy
Official title: Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Mastectomy
Drain policy
Pain
Upper limb function
Cosmetic outcome
Quilting
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgium Health Care Knowledge Centre
First posted: 2024-05-16
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre, pragmatic randomised controlled trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain in the mastectomy area scored by VAS
timeFrame: 6 months postoperative
measure: Upper limb function scored by QuickDASH
timeFrame: 6 months postoperative
measure: Cosmetic outcome scored by the patient on a 10-point scale
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Surgical Oncology, UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Ann Smeets, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: