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

Macromastia Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01284491
• Other study ID #: PEAK VP-00070
• Status: Terminated
• Phase: N/A
• First received: January 25, 2011
• Last updated: January 3, 2013
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2013
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macromastia

Intervention

Device:
• PEAK PlasmaBlade 4.0
The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
• Traditional Electrosurgery with scalpel
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Locations

Country	Name	City	State
United States	Gupta Plastic Surgery	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0-18 months following breast reduction surgery	No