Infection After Implant-based Breast Reconstruction | NCT06187649

Studies
Infection After Implant-based Breast Reconstruction

NCT06187649

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 22, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Breast Implant Infection

Interventions

breast reconstruction

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 15, 2023Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 18, 2023

First Submission Date that Met QC Criteria

Dec 18, 2023

First Posted Date

Jan 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2024

Last Update Posted Date

Mar 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ung Sik Jin, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
breast reconstruction	Procedure	breast expander/implant insertion for breast reconstruction following mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infection	Number of patients who developed requiring hospitalization-requiring infection	7 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received implant-based breast reconstruction following mastectomy between 2015 and 2020 in Seoul National University Hospital

Exclusion Criteria:

Patients who received flap surgery simultaneously with implant insertion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Implant-based breast reconstruction following mastectomy

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38489664	Derived	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.

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative