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Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02302001
Enrollment
21
Registered
2014-11-26
Start date
2014-11-30
Completion date
2016-07-31
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation

Keywords

Breast augmentation, Breast implants, Silicone implants, Breast surgery

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.

Interventions

DEVICESilicone Implant

Sponsors

Erbe-med
CollaboratorUNKNOWN
Tiger Biosciences, LLC.
CollaboratorINDUSTRY
Aristocrat Plastic Surgery and MedAesthetics
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Decreased postoperative pain and recovery after breast augmentationTwo weeks

Secondary

MeasureTime frame
Decreased risk of capsular contractureThree months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026