Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment296 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations1 site (Leuven)
StatusRecruiting
StartedSeptember 23, 2024
Main results expectedApril 2027
Study endsOctober 2027
Registry record updatedOctober 21, 2024
Trial IDNCT06415032 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.