Asian Outcomes of Primary Breast Augmentation

Breast Augmentation Clinical Trial

— BA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235285
• Other study ID #: Breast Augmentarion
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: May 2018
• Source: Winners Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 57 Years

Eligibility

Inclusion Criteria:

• primary case

Exclusion Criteria:

• secondary case

• breast reduction

Related Conditions & MeSH terms

• Breast Augmentation

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	The Department of Plastic Surgery, Winners Clinic	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Winners Clinic

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

1.Admas WP. Capsular contracture: what is it? what causes it? how can it be prevented and managed? Clinic Plastic Surg 36:119-126, 2009. 2.Spear SL, Murphy DK, Slicton A, et al. for the Inamed Silicon Breast Implant US Study Group. Inamed silicon breast implant core study results at 6 years. Plast Reconstr Surg 120;8s, 2007.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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