NCT06187649

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.

Trial Health

53
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

9 years

First QC Date

December 18, 2023

Last Update Submit

March 20, 2024

Conditions

Breast Implant Infection

Outcome Measures

Primary Outcomes (1)

  • Infection

    Number of patients who developed requiring hospitalization-requiring infection

    7 years

Interventions

breast reconstructionPROCEDURE

breast expander/implant insertion for breast reconstruction following mastectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Implant-based breast reconstruction following mastectomy

You may qualify if:

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

You may not qualify if:

  • Patients who received flap surgery simultaneously with implant insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38489664DERIVED

MeSH Terms

Interventions

Mammaplasty

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 2, 2024

Study Start

January 1, 2015

Primary Completion

December 15, 2023

Study Completion

December 31, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03