Infection After Implant-based Breast Reconstruction

Breast Implant Infection Clinical Trial

Official title:

A Systemic Review and Analysis of Factors and Outcomes in Breast Reconstruction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06187649
• Other study ID #: 2102-079-1197
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2024

Study information

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

Clinical 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.

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

Related Conditions & MeSH terms

• Breast Implant Infection
• Infections

Intervention

Procedure:
• breast reconstruction
breast expander/implant insertion for breast reconstruction following mastectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

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