Quilting sutures after mastectomy to improve recovery
Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06415032 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for unilateral mastectomy without immediate breast reconstruction.
Not a fit: Patients scheduled for mastectomy with immediate breast reconstruction or synchronous bilateral surgery may not benefit from this study.
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 performed: While the quilting suture technique is a novel approach, similar studies have shown promise in reducing complications associated with traditional drainage methods.
Eligibility criteria
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 this trial is running
Leuven
- Surgical Oncology, UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Ann Smeets, MD,PhD — UZ Leuven
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.