Asian Outcomes of Primary Breast Augmentation

NCT02235285 | Completed Results

• 1 other identifier: Breast Augmentarion
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Augmentation

Keywords

capsular contracture; reoperation; breast augmentation

Outcome Measures

Primary Outcomes (1)

• Post Surgical Complications and Reoperation Rate During Breast Augmentation

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

  5 years

Study Arms (1)

breast augmentation,reoperation

EXPERIMENTAL

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

Interventions

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.

breast augmentation,reoperation

Eligibility Criteria

• Age: 22 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• primary case

You may not qualify if:

• secondary case
• breast reduction

Sponsors & Collaborators

• Winners Clinic: lead

Study Sites (1)

The Department of Plastic Surgery, Winners Clinic

Seoul, 135-893, South Korea

Location

Related Publications (1)

• Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.

  PMID: 18090808 BACKGROUND

Results Point of Contact

• Title: Dr. Cheol Hwan Kim
• Organization: The Department of Plastic Surgery, Winners Clinic

winners511@naver.com

.+82.2.511.9446

Study Officials

• CHEOLHWAN KIM, M.D.

  Winners Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 4, 2018
• Results First Posted: September 21, 2015

Record last verified: 2018-05

Locations

KR (1)