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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
Sponsor:
Information provided by (Responsible Party):
Winners Clinic

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.

Condition or disease Intervention/treatment Phase
Breast Augmentation Procedure: primary breast augmentation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   22 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary case

Exclusion Criteria:

  • secondary case
  • breast reduction

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
The Department of Plastic Surgery, Winners Clinic
Seoul, Korea, Republic of, 135-893
Sponsors and Collaborators
Winners Clinic
Investigators
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Principal Investigator: CHEOLHWAN KIM, M.D. Winners Clinic

Publications:
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.

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Responsible Party: Winners Clinic
ClinicalTrials.gov Identifier: NCT02235285     History of Changes
Other Study ID Numbers: Breast Augmentarion
First Posted: September 9, 2014    Key Record Dates
Results First Posted: September 21, 2015
Last Update Posted: May 4, 2018
Last Verified: May 2018
Keywords provided by Winners Clinic:
capsular contracture
reoperation
breast augmentation
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs