## Protocol Section
### Identification Module
**NCT ID:** NCT06415032

**Acronym:** BE-Quilt

**Brief Title:** Quilting Sutures After Mastectomy

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

#### Organization Study ID Info
**ID:** S66948
#### Organization
**Class:** OTHER
**Full Name:** Universitaire Ziekenhuizen KU Leuven
### Status Module
#### Completion Date
**Date:** 2027-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Belgium Health Care Knowledge Centre

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitaire Ziekenhuizen KU Leuven

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- Mastectomy

- Drain policy

- Pain

- Upper limb function

- Cosmetic outcome

- Quilting

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A multicentre, pragmatic randomised controlled trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 296

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Mastectomy with Quilting sutures without drain placement

**Label:** Quilting sutures without drain placement

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Mastectomy with Conventional sutures with drain placement

**Label:** Conventional sutures with drain placement

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Quilting sutures without drain placement

**Description:** 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 is also approximated. Care is taken to prevent damage to nerves and blood vessels. No suction drains are placed. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference.

**Name:** Mastectomy with Quilting sutures without drain placement

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Conventional sutures with drain placement

**Description:** 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, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference. Drain output is recorded daily. Drain removal policy varies among participating centres. In some centres drain removal is based on volume of drained fluids while in other centres it depends on the postoperative time

**Name:** Mastectomy with Conventional sutures with drain placement

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** A non-inferiority margin of 10 mm was adopted, which implies that a difference between both arms up to 10 mm in favour of the standard approach would be clinically acceptable

**Measure:** Pain in the mastectomy area scored by VAS

**Time Frame:** 6 months postoperative

**Description:** A non-inferiority margin of 10 points was adopted, which implies that a difference between both arms up to 10 points in favour of the standard approach would be clinically acceptable.

**Measure:** Upper limb function scored by QuickDASH

**Time Frame:** 6 months postoperative

**Description:** A non-inferiority margin of 1 point on the 10-point scale was adopted which implies that a difference between both arms up to 1 point in favour of the standard approach would be clinically acceptable

**Measure:** Cosmetic outcome scored by the patient on a 10-point scale

**Time Frame:** 6 months postoperative

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Leuven

**Contacts:**

***Contact 1:***

- **Email:** hanne.vos@uzleuven.be

- **Name:** Hanne Vos, PhD

- **Phone:** 016340903

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ann Smeets, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Belgium

**Facility:** Surgical Oncology, UZ Leuven

**Zip:** 3000

#### Overall Officials

**Official 1:**

**Affiliation:** UZ Leuven

**Name:** Ann Smeets, MD,PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
