Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

Breast Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302001
• Other study ID #: fwa00022532
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2019
• Source: Aristocrat Plastic Surgery and MedAesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 60 Years

Eligibility

Inclusion Criteria:

• silicone breast implants candidate

Exclusion Criteria:

• history of breast cancer

• inability to conform to post operative questionnaire and recovery follow up

Related Conditions & MeSH terms

• Breast Augmentation
• Pain, Postoperative

Intervention

Device:
• Silicone Implant

Locations

Country	Name	City	State
United States	Aristocrat Plastic Surgery & MedAesthetics	Great Neck	New York
United States	Aristocrat Plastic Surgery	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Aristocrat Plastic Surgery and MedAesthetics	Erbe-med, Sientra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased postoperative pain and recovery after breast augmentation		Two weeks
Secondary	Decreased risk of capsular contracture		Three months