Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Not Applicable

Withdrawn

• Conditions: Macromastia (Symptomatic)

• Registration Number: NCT01404351
• Lead Sponsor: Medtronic Surgical Technologies

Brief Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Age between 18 and 70
2. Physically healthy, stable weight
3. No smoking <1 month prior to surgery and during study.
4. Desiring bilateral breast reduction
5. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
6. Subject must be willing and able to comply with specified follow-up evaluations.
7. Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.

Exclusion Criteria

1. Age younger than 18 or greater than 70 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking <1 month prior to surgery or during study
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 are status-post gastric banding or gastric bypass
13. Currently enrolled in another investigational device or drug trial
14. Unable to follow instructions or complete follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in pain	24 hours and first 10 days post-op	The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily.

Secondary Outcome Measures

Name	Time	Method
Operative performance	Intraoperatively on day 0	Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.
Adverse events	1 month post-operatively	Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.
Cutaneous scarring	Up to one year post-operatively	Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.

Trial Locations

Locations (1)

Gonyon Cosmetic & Plastic Surgery, PC; 🇺🇸 Johnstown, Colorado, United States