NCT06332937

Brief 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

Trial Health

55
Monitor

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 Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Breast Implant; Complications

Outcome Measures

Primary Outcomes (1)

  • Infection

    Number of patients who developed requiring hospitalization-requiring infection

    7 years

Interventions

postmastectomy breast reconstructionPROCEDURE

postmastectomy immediate breast reconstruction

Eligibility Criteria

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

Immediate 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

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

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

March 20, 2024

First Posted

March 27, 2024

Study Start

February 22, 2021

Primary Completion

December 15, 2023

Study Completion

December 31, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations

KR(1)