Quilting Sutures After Mastectomy (BE-Quilt)
Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Leuven, Belgium, 3000
- Recruiting
- Surgical Oncology, UZ Leuven
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Contact:
- Hanne Vos, PhD
- Phone Number: 016340903
- Email: hanne.vos@uzleuven.be
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Principal Investigator:
- Ann Smeets, MD, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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.
|
|
Active Comparator: 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, 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain in the mastectomy area scored by VAS
Time Frame: 6 months postoperative
|
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
|
6 months postoperative
|
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Upper limb function scored by QuickDASH
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
|
Cosmetic outcome scored by the patient on a 10-point scale
Time Frame: 6 months postoperative
|
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
|
6 months postoperative
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ann Smeets, MD,PhD, UZ Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S66948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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