Clinical trial · Observational
Evaluation of SOMAVAC 100 Sustained Vacuum System
Evaluation of SOMAVAC 100 Sustained Vacuum System Versus Manual Suction Bulbs After Mastectomy With Immediate Breast Reconstruction
NCT04845256CI-TRIAL-00063870completedClinicalTrials.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)
The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOMAVAC 100 Sustained Vacuum System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- SOMAVAC 100 Sustained Vacuum System
- description
- New sustained vacuum system
- interventionNames
- Device: SOMAVAC 100 Sustained Vacuum System
Primary outcomes (2)
- measure
- Impact of the SOMAVAC continuous suction device on postoperative fluid drainage after mastectomy reconstruction
- timeFrame
- Approximately 3 months
- description
- Given that patients enrolled will have bilateral reconstruction, one side will have the SOMAVAC continuous suction device and the other side will have standard manual suction bulbs. The fluid drained on each side will be measured in milliliters over 24 hour periods, recorded, and analyzed for any difference.
- measure
- The SOMAVAC continuous suction device and seroma development on reconstructed mastectomy patients
- timeFrame
- approximately 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant * Capable of providing informed consent * Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent. Exclusion Criteria: * Reconstruction is not post-mastectomy * Pregnant or lactating females * Patients needing more than 2 drains per breast * Patients on steroids or other immune modulators known to impact healing * Patients who are likely to not complete the study * Patient who, in the opinion of the investigator, are unlikely to comply with the protocol * Patients who have participated in this trial previously and who were withdrawn * Patients with known allergies to contacting materials (i.e. latex, metal, etc.) * Patients who received neoadjuvant chemotherapy or radiotherapy within the last 6 months * Has any medical condition such as obesity (BMI\>40), uncontrolled diabetes (HbA1c\>7%) and/or immunosuppression.
References
Publications (0)
Data not yet available
No reference posted for this study.