Seroma
Conditions
Keywords
Mastectomy, Seroma
Brief summary
Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.
Interventions
DEVICELow thermal electrosurgery system
PEAK Plasmablade
DEVICEConventional Electrocautery
Conventional Electrocautery
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female aged \>18 years old * Patients that fulfill the indication of mastectomy * Medium-sized breast volume (Breast weight \< 1500 grams)
Exclusion criteria
* Patients who cannot complete the informed consent * Patients with ASA CLASS \> 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drainage volume after surgery | Up to 24 weeks | Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative Pain | Up to 24 weeks | Post-operative Pain measured using 0-10 Numeric pain scale |
| Patient's Hospital costs | up to 1 week | Expenses that the patient has to pay while staying in the hospital |
| Wound infection | Up to 24 weeks | Wound infection after surgery |
Countries
Thailand
Contacts
Primary ContactPiratthima Vachiraprakarnsakul
Backup ContactSuebwong Chuthapisith
Outcome results
None listed