Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

February 3, 2019 updated by: Aristocrat Plastic Surgery and MedAesthetics

Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Great Neck, New York, United States, 11021
        • Aristocrat Plastic Surgery & MedAesthetics
      • New York, New York, United States, 10019
        • Aristocrat Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • silicone breast implants candidate

Exclusion Criteria:

  • history of breast cancer
  • inability to conform to post operative questionnaire and recovery follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Breast Augmentation
Device: Silicone Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decreased postoperative pain and recovery after breast augmentation
Time Frame: Two weeks
Two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Decreased risk of capsular contracture
Time Frame: Three months
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristocrat Plastic Surgery and MedAesthetics

Collaborators

Sientra, Inc.
Erbe-med

Investigators

  • Principal Investigator: Kevin Tehrani, M.D., Aristocrat Plastic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 3, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fwa00022532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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