Clinical trial · Interventional
Seroma Reduction After Mastectomy
A Multi-center, Double Blinded Randomized Controlled Trial Evaluating Closure of the Dead Space After Mastectomy Using Sutures or Tissue Glue Versus Conventional Closure. Protocol for the Seroma Reduction After Mastectomy (SAM) Trial
- 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)
Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction. No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.
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 |
|---|---|---|---|
| Aspiration | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artiss | Drug | — | UNRESOLVED |
| Conventional | Procedure | — | UNRESOLVED |
| vicryl sutures | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- conventional wound closure
- description
- The skin flaps will not undergo further treatment in this group.
- interventionNames
- Procedure: Conventional
- type
- EXPERIMENTAL
- label
- flap fixation with vicryl sutures
- description
- The skin flaps will be sutured on to the pectoral muscle after having performed the mastectomy.
- interventionNames
- Procedure: vicryl sutures
- type
- EXPERIMENTAL
- label
- Artiss tissue glue
- description
- ARTISS tissue glue will be applied to the skin flaps after mastectomy
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 or modified radical mastectomy Exclusion Criteria: * Patients undergoing breast conserving therapy * Patients undergoing direct breast reconstruction * Unable to comprehend implications and extent of study and sign for informed consent
References
Publications (3)
- RESULTvan Bastelaar J, Beckers A, Snoeijs M, Beets G, Vissers Y. Flap fixation reduces seroma in patients undergoing mastectomy: a significant implication for clinical practice. World J Surg Oncol. 2016 Mar 8;14:66. doi: 10.1186/s12957-016-0830-8. PMID 26952040
- DERIVEDde Rooij L, van Kuijk SMJ, Granzier RWY, Hintzen KFH, Heymans C, Theunissen LLB, von Meyenfeldt EM, van Essen JA, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial). Ann Surg Oncol. 2021 May;28(5):2599-2608. doi: 10.1245/s10434-020-09225-8. Epub 2020 Oct 19. PMID 33078318
- DERIVEDvan Bastelaar J, Granzier R, van Roozendaal LM, Beets G, Dirksen CD, Vissers Y. A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial. BMC Cancer. 2018 Aug 17;18(1):830. doi: 10.1186/s12885-018-4740-8. PMID 30119663