Breast Augmentation
Conditions
Keywords
capsular contracture, reoperation, breast augmentation
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.
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.
Interventions
PROCEDUREprimary 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.
Sponsors
Winners Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 57 Years
Healthy volunteers
Yes
Inclusion criteria
* primary case
Exclusion criteria
* secondary case * breast reduction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Surgical Complications and Reoperation Rate During Breast Augmentation | 5 years | The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate. |
Countries
South Korea
Participant flow
Recruitment details
Retrospective analysis was performed on 162 patients undergoing primary breast augmentation by a single surgeon during a 5-year period from 2010 to 2015.
Pre-assignment details
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) .
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon. | 162 |
| Total | 162 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 162 Participants |
| Age, Continuous | 33.98 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Korea, Republic of | 162 participants |
| Sex: Female, Male Female | 162 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 162 |
| serious Total, serious adverse events | 3 / 162 |
Outcome results
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.
Time frame: 5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast Augmentation, Reoperation | Post Surgical Complications and Reoperation Rate During Breast Augmentation | reoperation rate | 1.85 percentage of participants | Standard Deviation 0.05 |
| Breast Augmentation, Reoperation | Post Surgical Complications and Reoperation Rate During Breast Augmentation | complications | 1.85 percentage of participants | Standard Deviation 0.05 |