Quilting sutures after mastectomy to improve recovery
Official title: Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial
Run by Universitaire Ziekenhuizen KU Leuven · NCT06415032 · Data updated 2026-11-12
This study is testing if a special type of stitching after breast surgery can help women recover better and avoid complications compared to regular stitching.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 296 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | September 23, 2024 |
| Main results expected | April 2027 |
| Study ends | October 2027 |
| Registry record updated | October 21, 2024 |
| Trial ID | NCT06415032 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for unilateral mastectomy without immediate breast reconstruction.
✕Probably not a fit
Patients scheduled for mastectomy with immediate breast reconstruction or synchronous bilateral surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of quilting sutures compared to conventional sutures with drain placement after mastectomy in patients with breast cancer. The study aims to reduce complications such as seroma formation, discomfort, and the need for additional healthcare interventions. By suturing the skin directly to the underlying muscle, the trial seeks to eliminate the need for drainage, which can introduce infection and discomfort. Participants will be monitored for pain, upper limb function, and cosmetic outcomes following the procedure.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced complications for breast cancer patients undergoing mastectomy.
How similar studies have gone: While the quilting suture technique is a novel approach, similar studies have shown promise in reducing complications associated with traditional drainage methods.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Surgical Oncology, UZ Leuven
Leuven, Belgium Recruiting
Study contacts
- Principal investigator: Ann Smeets, MD,PhD — UZ Leuven
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.