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NCT04773457 Clinical Trial

Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Surgical Site Infection Clinical Trial

Official title:
Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04773457
Other study ID # IRB-P00037804
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date December 1, 2023

Study information
Verified date April 2023
Source Boston Children's Hospital
Contact Koichi Yuki, MD
Phone 617-355-6225
Email koichi.yuki@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Surgical site infections (SSIs) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. The objective of this study is to assess the neutrophil functional profiles and their associations with SSIs.

Recruitment information / eligibility
Status Recruiting
Enrollment 220
Est. completion date December 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Months to 19 Years
Eligibility Inclusion Criteria: - scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery Exclusion Criteria: - On chronic immunosuppressive drugs such as chronic corticosteroid use - preexisting immunodeficiency diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Surgical Site Infection
infection at the site of the surgery (spine or abdomen)

Locations
Country Name City State
United States Boston Children's Hopsital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neutrophil populations compare neutrophil population between patients with SSI and without SSI by delineating transcriptomic profiles up to 3 days
Primary Neutrophil functional impairment illustrate neutrophil subpopulation associated with neutrophil functional impairment and SSIs by probing phagocytosis and reactive oxygen species formation up to 3 days
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