Macromastia
Conditions
Keywords
Breast reduction, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
Brief summary
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.
Detailed description
Subjects attended one of two evaluation dates scheduled on January 21, 2011 and February 23, 2011. During this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the Patient Scar Assessment Scale. Following subjects' self-evaluation, each subject was evaluated by three evaluators using the Observer Scar Assessment Scale.
Interventions
DEVICEPEAK PlasmaBlade 4.0
The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 70 2. Physically healthy, stable weight 3. Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery. 4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 5. Subject must be willing and able to comply with specified follow-up evaluations. 6. Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study.
Exclusion criteria
1. Age younger than 18 or greater than 70 years old 2. Anticoagulation therapy which cannot be discontinued 3. Smoking (continuous; any substance) 4. Infection (local or systemic) 5. Cognitive impairment or mental illness 6. Severe cardiopulmonary deficiencies 7. Known coagulopathy 8. Immunocompromised 9. Prior history of breast cancer 10. Kidney disease (any type) 11. Currently taking any medication known to affect healing 12. Subjects who did not participated in the PEAK PlasmaBlade bilateral breast reduction study 13. Unable to follow instructions or complete follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Quality | 0-18 months following breast reduction surgery | The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions. |
Countries
United States
Participant flow
Recruitment details
Subjects' breasts were randomized individually to the PEAK PlasmaBlade or SOC group.
Participants by arm
| Arm | Count |
|---|---|
| Total Study Population | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study termination | 13 |
Baseline characteristics
| Characteristic | Total Study Population |
|---|---|
| Age, Customized 18 to 70 years | 13 participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Scar Quality
The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.
Time frame: 0-18 months following breast reduction surgery
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.