Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

Aristocrat Plastic Surgery and MedAesthetics

Status: Completed

Conditions: Breast Augmentation

Treatments: Device: Silicone Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02302001

fwa00022532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 22 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• silicone breast implants candidate

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Primary Breast Augmentation

Experimental group

Treatment:

Device: Silicone Implant