Breast Implant; ComplicationsNCT06332937
Breast Reconstruction
An observational study of Breast Implant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Implant; Complications
- What is being tested?
- postmastectomy breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Immediate implant-based breast reconstruction following mastectomy
Who may be able to join
- Patients who received implant-based breast reconstruction following mastectomy between 2015 and 2020 in Seoul National University Hospital
Who cannot join
- Patients who received flap surgery simultaneously with implant insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complication Following Postmastectomy Breast Reconstruction
Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction
- Conditions
- Breast Implant; Complications
- Being tested
- postmastectomy breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postmastectomy breast reconstructionProcedure or surgery
postmastectomy immediate breast reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Number of patients who developed requiring hospitalization-requiring infection
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start22 Feb 2021
- Primary completion15 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ung Sik Jin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332937
- Sponsor's protocol ID
- H-2102-079-1197
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complication Following Postmastectomy Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06332937
- Acronym / sponsor ID
- H-2102-079-1197
- Conditions
- Breast Implant; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immediate implant-based breast reconstruction following mastectomy
Key inclusion criteria (1 listed)
- Patients who received implant-based breast reconstruction following mastectomy between 2015 and 2020 in Seoul National University Hospital
Key exclusion criteria (1 listed)
- Patients who received flap surgery simultaneously with implant insertion
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 |
|---|---|---|
| postmastectomy breast reconstructionpostmastectomy immediate breast reconstruction | Procedure or surgery | – |
Primary outcome
Infection
Time frame: 7 years
Number of patients who developed requiring hospitalization-requiring infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications, run by Seoul National University Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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?
Results are not available in the source record.
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?
Infection (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.