Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
Primary Purpose
Breast Augmentation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silicone Implant
Sponsored by

About this trial
This is an interventional treatment trial for Breast Augmentation focused on measuring Breast augmentation, Breast implants, Silicone implants, Breast surgery
Eligibility Criteria
Inclusion Criteria:
- silicone breast implants candidate
Exclusion Criteria:
- history of breast cancer
- inability to conform to post operative questionnaire and recovery follow up
Sites / Locations
- Aristocrat Plastic Surgery & MedAesthetics
- Aristocrat Plastic Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Primary Breast Augmentation
Arm Description
Outcomes
Primary Outcome Measures
Decreased postoperative pain and recovery after breast augmentation
Secondary Outcome Measures
Decreased risk of capsular contracture
Full Information
NCT ID
NCT02302001
First Posted
November 24, 2014
Last Updated
February 3, 2019
Sponsor
Aristocrat Plastic Surgery and MedAesthetics
Collaborators
Erbe-med, Sientra, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02302001
Brief Title
Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
Official Title
Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aristocrat Plastic Surgery and MedAesthetics
Collaborators
Erbe-med, Sientra, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study is designed to differentiate parameters of pain between randomized laterality using no touch technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. Patients must undergo evaluation at consultation and surgical quote is provided.
Detailed Description
Breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. Minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. Minimal injury no touch dissection techniques have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. Patient's record pain scores at regular intervals in the postoperative period. Physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Augmentation
Keywords
Breast augmentation, Breast implants, Silicone implants, Breast surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Breast Augmentation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Silicone Implant
Primary Outcome Measure Information:
Title
Decreased postoperative pain and recovery after breast augmentation
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Decreased risk of capsular contracture
Time Frame
Three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
silicone breast implants candidate
Exclusion Criteria:
history of breast cancer
inability to conform to post operative questionnaire and recovery follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Tehrani, M.D.
Organizational Affiliation
Aristocrat Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aristocrat Plastic Surgery & MedAesthetics
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Aristocrat Plastic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
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Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
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