Clinical trial · Interventional
Seroma Reduction and Drain Free Mastectomy
NCT04035590CI-TRIAL-00067845SARAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Seroma | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drain | Procedure | — | UNRESOLVED |
| With drain | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- With drain
- description
- Patients undergo mastectomy with flap fixation and low vacuum drainage.
- interventionNames
- Procedure: With drain
- type
- EXPERIMENTAL
- label
- No drain
- description
- Patients undergo mastectomy with flap fixation and low vacuum drainage is omitted.
- interventionNames
- Procedure: No drain
Primary outcomes (1)
- measure
- Seroma aspiration of clinically significant seroma
- timeFrame
- During first six months post-operative
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDde Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. BMC Cancer. 2020 Aug 7;20(1):735. doi: 10.1186/s12885-020-07242-0. PMID 32767988