Asian Outcomes of Primary Breast Augmentation (BA)
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|ClinicalTrials.gov Identifier: NCT02235285|
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : September 21, 2015
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Augmentation||Procedure: primary breast augmentation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||January 2015|
Experimental: breast augmentation,reoperation
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.
Procedure: primary breast augmentation
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235285
|Korea, Republic of|
|The Department of Plastic Surgery, Winners Clinic|
|Seoul, Korea, Republic of, 135-893|
|Principal Investigator:||CHEOLHWAN KIM, M.D.||Winners Clinic|