Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

• Sponsor: Aristocrat Plastic Surgery and MedAesthetics (Other)
• Overall Status: Completed
• CT.gov ID: NCT02302001
• Collaborator: Erbe-med (Other), Sientra, Inc. (Industry)
• Enrollment: 21
• Locations: 2
• Arm: 1
• Duration (Months): 20
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation	Device: Silicone Implant	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Decreased postoperative pain and recovery after breast augmentation [Two weeks]

Secondary Outcome Measures

1. Decreased risk of capsular contracture [Three months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• silicone breast implants candidate

Exclusion Criteria:

• history of breast cancer

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aristocrat Plastic Surgery & MedAesthetics	Great Neck	New York	United States	11021
2	Aristocrat Plastic Surgery	New York	New York	United States	10019

Sponsors and Collaborators

• Aristocrat Plastic Surgery and MedAesthetics
• Erbe-med
• Sientra, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aristocrat Plastic Surgery and MedAesthetics
• ClinicalTrials.gov Identifier: NCT02302001
• Other Study ID Numbers: fwa00022532
• First Posted: Nov 26, 2014
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Aristocrat Plastic Surgery and MedAesthetics: Breast augmentation; Breast implants; Silicone implants; Breast surgery
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Feb 5, 2019