Trials / Completed
CompletedNCT02302001
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Aristocrat Plastic Surgery and MedAesthetics · Academic / Other
- Sex
- Female
- Age
- 22 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silicone Implant |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2014-11-26
- Last updated
- 2019-02-05
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02302001. Inclusion in this directory is not an endorsement.