Reducing seroma formation after mastectomy without using drains
Seroma Reduction and Drain Free Mastectomy
NA · Zuyderland Medisch Centrum · NCT04035590
This study is testing if skipping drains after mastectomy can help prevent fluid buildup, called seromas, in patients who have flap fixation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Zuyderland Medisch Centrum (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Sittard, Limburg) |
| Trial ID | NCT04035590 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether omitting drains after mastectomy and flap fixation can reduce the incidence of seroma formation, which is a common complication that can lead to discomfort and additional medical visits. The research will compare outcomes between patients who undergo mastectomy with flap fixation with and without the use of closed-suction drainage. By focusing on seroma aspiration as the primary outcome, the study seeks to provide evidence for a potential change in standard surgical practice. This randomized controlled trial is necessary due to the lack of large-scale studies on this topic.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old who require a mastectomy.
Not a fit: Patients undergoing breast conserving therapy, modified radical mastectomy, or direct breast reconstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce patient discomfort and the need for additional medical interventions related to seroma formation.
How similar studies have performed: While there have been small case series on flap fixation, this is the first large randomized controlled trial specifically comparing flap fixation with and without drainage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years * Female sex * Indication for mastectomy Exclusion Criteria: * Patients undergoing breast conserving therapy * Patients undergoing modified radical mastectomy * Patients undergoing direct breast reconstruction * Unable to comprehend implications and extent of study and sign for informed consent * Patients with radiation therapy of unilateral breast in previous history
Where this trial is running
Sittard, Limburg
- Zuyderland Medisch Centrum — Sittard, Limburg, Netherlands (RECRUITING)
Study contacts
- Study coordinator: James van Bastelaar, MD, PhD
- Email: j.vanbastelaar@zuyderland.nl
- Phone: +31884591870
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.
Conditions: Breast Cancer, Seroma, Wound Complication, Mastectomy, Drain