Breast Implant InfectionNCT06187649
Infection After Implant-based Breast Reconstruction
An observational study of Breast Implant Infection, run by Seoul National University Hospital.
Trial summary
Infections following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with infection following two-stage implant-based reconstruction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Implant Infection
- What is being tested?
- breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 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: 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
About this study
Official title: A Systemic Review and Analysis of Factors and Outcomes in Breast Reconstruction
Infections following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with infection following two-stage implant-based reconstruction.
- Conditions
- Breast Implant Infection
- Being tested
- breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast reconstructionProcedure or surgery
breast expander/implant insertion for breast reconstruction following mastectomy
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 posted2 Jan 2024
- Study start1 Jan 2015
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Implant InfectionStudies 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
- NCT06187649
- Sponsor's protocol ID
- 2102-079-1197
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ha JH, Ahn S, Kim HK, Lee HB, Moon HG, Han W, Hong KY, Chang H, Lee GK, Choi J, Jin US. Dynamic insights into infection risk over time in two-stage implant-based breast reconstruction: a retrospective cohort study. Int J Surg. 2024 Jun 1;110(6):3433-3439. doi: 10.1097/JS9.0000000000001235.
PubMed 38489664
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systemic Review and Analysis of Factors and Outcomes in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06187649
- Acronym / sponsor ID
- 2102-079-1197
- Conditions
- Breast Implant Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jan 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.
Infections following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with infection 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
- 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 |
|---|---|---|
| breast reconstructionbreast expander/implant insertion for breast reconstruction following mastectomy | 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 22 Mar 2024.
- Derived from this study: PubMed 38489664Ha JH, Ahn S, Kim HK, Lee HB, Moon HG, Han W, Hong KY, Chang H, Lee GK, Choi J, Jin US. Dynamic insights into infection risk over time in two-stage implant-based breast reconstruction: a retrospective cohort study. Int J Surg. 2024 Jun 1;110(6):3433-3439. doi: 10.1097/JS9.0000000000001235.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant Infection, run by Seoul National University Hospital.
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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT06187649, 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 22 Mar 2024.