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NCT06332937 Clinical Trial

Breast Reconstruction

Breast Implant; Complications Clinical Trial

Official title:
Complication Following Postmastectomy Breast Reconstruction

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06332937
Other study ID # H-2102-079-1197
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 22, 2021
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5000
Est. completion date December 31, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• postmastectomy breast reconstruction
postmastectomy immediate breast reconstruction

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infection Number of patients who developed requiring hospitalization-requiring infection 7 years
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