Mastectomy; Lymphedema
Conditions
Keywords
comparison of ablation devices
Brief summary
A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE DEVICE EFFICACY BETWEEN THE HELIXAR ELECTROSURGICAL GENERATOR (HEG) VS. CONVENTIONAL ELECTROSURGICAL COAGULATION (CEC) FOR CUTTING AND/OR COAGULATION OF TISSUE DURING MASTECTOMY PROCEDURES
Detailed description
The objective of this study is to evaluate device efficacy between the HelixAR Electrosurgical Generator (HEG) and Conventional Electrosurgical Coagulation (CEC) Systems for cutting and/or coagulation of tissue during mastectomy procedures and reconstructive surgery. The study is designed and powered to demonstrate the superiority of the HEG to CEC in relation to a key efficacy measure: post-mastectomy procedure time to hemostasis. Secondary outcome measures include: infection, drain duration, total drain output, blood loss, and device related adverse events. These outcomes will be evaluated in a controlled population undergoing mastectomy procedures.
Interventions
DEVICEAblation
comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.
Sponsors
SurgiQuest, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Perspective, randomized, concurrently controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 80 years of age; 2. Capable and willing to give informed consent; 3. Acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. All subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest.
Exclusion criteria
1. Advanced refusal of blood transfusion, if necessary; 2. Active systemic or cutaneous infection or inflammation; 3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4. Uncontrolled diabetes mellitus 5. Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count \< 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6. Severe co-existing morbidities having a life expectancy of less than 30 days; 7. Currently involved in any other investigational clinical studies that could influence outcomes; 8. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 9. Renal insufficiency (serum creatinine of \> 2.5 mg/dl); 10. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 11. Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time measured from post-mastectomy to hemostasis for each operated breast. | Inter-operative | time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| drain output | up to two weeks post surgery | ml |
Other
| Measure | Time frame | Description |
|---|---|---|
| infection rate | two months from procedure | comparison between arms |
Countries
United States
Contacts
Primary Contactcynthia C Harris, BS
Backup ContactMichael A Daniel, BS, MS,MB
Outcome results
None listed