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OpenTrials
Completed

NCT Number: NCT02235285

Asian Outcomes of Primary Breast Augmentation

In 162 Asian patients, primary breast augmentations were performed by a single surgeon during 5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation using single antibiotic breast irrigation by a single surgeon's practice and examines the comparison of Asian and Western outcomes in primary breast augmentation.

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Key information

Conditions

Age range

22 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Department of Plastic Surgery, Winners Clinic

Seoul, 135-893, South Korea

About this study

A retrospective chart review was performed to examine a total of 162 patients received the same brand of implants for primary breast augmentation under sedative anesthesia (propofol infusion) in a single surgeon's practice. Asian patients' demographics, preoperative and postoperative measurements, surgical technique (single antibiotic breast irrigation), implant type, size, texture, soft tissue coverage, implant placement, incision approach, complications, and incidence of reoperation were documented.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • primary case

Exclusion criteria

  • secondary case
  • breast reduction

Treatment and study plan

primary breast augmentation

Procedure

With the patient under sedative anesthesia, wide preparation and draping by using povidone-iodine are performed with using talc-free gloves and povidone-iodine gauze nipple shields. Tumescent solution is infiltrated in the precise plane. Pockets are developed precisely with blunt dissection with fingers and instruments under both direct and indirect visions simultaneously, if needed, with using endoscopy, while careful hemostasis done. After dissection, two pockets are irrigated with 300ml of single antibiotic solution without active evacuation of the irrigation. When re-draping and re-preparation by using povidone-iodine are performed before implant insertion, a new pair of talc-free gloves is used and cleansed with the single antibiotic solution.

Primary outcomes

  1. Post Surgical Complications and Reoperation Rate During Breast Augmentation

    Time frame: 5 years

    The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.

Sponsors and collaborators

Lead sponsor

Winners Clinic

Other

Registry information

Official study title

Asian Outcomes of Primary Breast Augmentation in 162 Consecutive Cases Using Single Antibiotic Breast Irrigation by A Single Surgeon Under Sedative Anesthesia (Propofol Infusion)

Acronym: BA

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 9, 2014
Registry last updated
May 4, 2018

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.

Published trials that share one or more normalized conditions with this study.