Quilting Sutures After Mastectomy - Trial NCT06415032
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Study Focus
Sponsor & Location
Universitaire Ziekenhuizen KU Leuven
Timeline & Enrollment
N/A
Jun 01, 2024
Jun 01, 2027
Primary Outcome
Pain in the mastectomy area scored by VAS,Upper limb function scored by QuickDASH,Cosmetic outcome scored by the patient on a 10-point scale
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06415032
Non-Device Trial