Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

Not Applicable

Completed

• Conditions: Breast Augmentation
• Interventions: Device: Silicone Implant

• Registration Number: NCT02302001
• Lead Sponsor: Aristocrat Plastic Surgery and MedAesthetics

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-26
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-03
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• silicone breast implants candidate

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary Breast Augmentation	Silicone Implant	-

Primary Outcome Measures

Name	Time	Method
Decreased postoperative pain and recovery after breast augmentation	Two weeks

Secondary Outcome Measures

Name	Time	Method
Decreased risk of capsular contracture	Three months

Trial Locations

Locations (2)

Aristocrat Plastic Surgery & MedAesthetics; 🇺🇸 Great Neck, New York, United States

Aristocrat Plastic Surgery; 🇺🇸 New York, New York, United States