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Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

NCT ID: NCT02302001

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Augmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary Breast Augmentation

Group Type EXPERIMENTAL

Silicone Implant

Intervention Type DEVICE

Interventions

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Silicone Implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* silicone breast implants candidate

Exclusion Criteria

* history of breast cancer
* inability to conform to post operative questionnaire and recovery follow up
Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Erbe-med

UNKNOWN

Sponsor Role collaborator

Tiger Biosciences, LLC.

INDUSTRY

Sponsor Role collaborator

Aristocrat Plastic Surgery and MedAesthetics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Tehrani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Aristocrat Plastic Surgery

Locations

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Aristocrat Plastic Surgery & MedAesthetics

Great Neck, New York, United States

Site Status

Aristocrat Plastic Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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fwa00022532

Identifier Type: -

Identifier Source: org_study_id

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