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OpenTrials
Completed

NCT Number: NCT02302001

Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain

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.

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Key information

Conditions

Breast Augmentation

Age range

22 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aristocrat Plastic Surgery & MedAesthetics, Great Neck, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • silicone breast implants candidate

Exclusion criteria

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

Treatment and study plan

Silicone Implant

Device

Primary outcomes

  1. Decreased postoperative pain and recovery after breast augmentation

    Time frame: Two weeks

Secondary outcomes

  1. Decreased risk of capsular contracture

    Time frame: Three months

Sponsors and collaborators

Lead sponsor

Aristocrat Plastic Surgery and MedAesthetics

Other

Collaborators

  • Erbe-med
  • Tiger Biosciences, LLC.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2014
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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