NCT06415032

Quilting Sutures After Mastectomy

Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial
Universitaire Ziekenhuizen KU Leuven·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Mastectomy with Quilting sutures without drain placement
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Universitaire Ziekenhuizen KU Leuven
Location
Leuven, Belgium
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Jun 01, 2027
Enrollment
296 participants
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
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06415032
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06415032 through Pure Global AI's free database. This phase not specified trial is sponsored by Universitaire Ziekenhuizen KU Leuven and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 296 participants.

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