Clinical trial · Interventional
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low patient enrollment and no clinical findings.
Summary
Brief summary (as posted)
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin
Conditions
Conditions (2)
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 |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast reconstruction | Procedure | — | UNRESOLVED |
| fibrin sealant (Beriplast P, TISSEEL VH) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (fibrin sealant)
- description
- Patients undergo sharp dissection technique with fibrin sealant closure.
- interventionNames
- Drug: fibrin sealant (Beriplast P, TISSEEL VH)
- Procedure: breast reconstruction
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard electrocoagulation)
- description
- Patients undergo standard electrocoagulation dissection technique.
- interventionNames
- Procedure: breast reconstruction
Primary outcomes (1)
- measure
- Proportion of Patients in Each Arm Who Develop Post-operative Seromas
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU) * These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon * History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant * Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery
References
Publications (0)
Data not yet available