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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHEOLHWAN KIM, M.D. | Winners Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Department of Plastic Surgery, Winners Clinic | Seoul | 135-893 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18090808 | Background | 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. |
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This study presents data for 162 primary breast augmentation in either alone (n=152; 93.82 percent) or in conjunction with mastopexy (n=9; 5.56 percent) and inverted nipple correction (n=1; 0.62 percent) .
Retrospective analysis was performed on 162 patients undergoing primary breast augmentation by a single surgeon during a 5-year period from 2010 to 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Augmentation,Reoperation | The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of participants | 5 years |
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5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Augmentation, Reoperation | The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Capsular contracture | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cheol Hwan Kim | The Department of Plastic Surgery, Winners Clinic | .+82.2.511.9446 | winners511@naver.com |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 3 |
| 162 |
| 0 |
| 162 |
| Rippling | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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