A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0

Not Applicable

Terminated

• Conditions: Macromastia
• Interventions: Device: Traditional Electrosurgery with scalpel; Device: PEAK PlasmaBlade 4.0

• Registration Number: NCT01284491
• Lead Sponsor: Medtronic Surgical Technologies

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2012-11-29
• Results First Submitted QC: 2012-11-29
• Status Verified: 2013-01
• Results First Posted: 2013-01-03
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SOC)	Traditional Electrosurgery with scalpel	Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
PlasmaBlade	PEAK PlasmaBlade 4.0	The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gupta Plastic Surgery; 🇺🇸 San Diego, California, United States