Clinical Trials Directory

Trials / Completed

CompletedNCT02235285

Asian Outcomes of Primary Breast Augmentation

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
162 (actual)
Sponsor
Winners Clinic · Academic / Other
Sex
All
Age
22 Years – 57 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREprimary breast augmentationWith 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.

Timeline

Start date
2010-01-01
Primary completion
2014-04-01
Completion
2015-01-01
First posted
2014-09-09
Last updated
2018-05-04
Results posted
2015-09-21

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02235285. Inclusion in this directory is not an endorsement.