Breast AugmentationBANCT02235285
Asian Outcomes of Primary Breast Augmentation
A study testing primary breast augmentation in people with Breast Augmentation, run by Winners Clinic at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 22 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation
- What is being tested?
- primary breast augmentation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- primary case
Who cannot join
- secondary case
- breast reduction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Department of Plastic Surgery, Winners Clinic
Seoul, 135-893
About this study
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)
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.
Read the 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.
- Conditions
- Breast Augmentation
- Being tested
- primary breast augmentation
- Keywords
- capsular contracture, reoperation, breast augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary breast augmentationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: primary breast augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Surgical Complications and Reoperation Rate During Breast Augmentation
The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winners Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHEOLHWAN KIM, M.D., Principal investigator, Winners Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235285
- Sponsor's protocol ID
- Breast Augmentarion
- Acronym
- BA
- Status last verified
- May 2018
- First submitted
- 5 Sep 2014
- Last updated
- 4 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18090808
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02235285
- Acronym / sponsor ID
- BA / Breast Augmentarion
- Conditions
- Breast Augmentation
- Keywords
- capsular contracture, reoperation, breast augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Winners ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 21 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast augmentation,reoperation | Experimental | Procedure: primary breast augmentationA 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. |
Who may qualify
- Ages
- 22 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- primary case
Key exclusion criteria (2 listed)
- secondary case
- breast reduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary breast augmentationWith 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. | Procedure or surgery | breast augmentation,reoperation |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18090808Spear 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.
Related trials for Breast Augmentation
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
Recruiting
Improved Breast Enlargement Using the Subject's Own Fat Tissue
Breast Augmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHEOLHWAN KIM, M.D. principal investigator
Winners Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary breast augmentation in people with Breast Augmentation, run by Winners Clinic at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Surgical Complications and Reoperation Rate During Breast Augmentation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.