Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

April 10, 2023 updated by: Koichi Yuki, Boston Children's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients presenting for elective surgical procedures (open gastrointestinal surgery or spine fusion surgery) at Boston Children's Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spine Surgery
Pediatric patients presenting for elective spine fusion surgery at Boston Children's Hospital
Other: Surgical Site Infection
infection at the site of the surgery (spine or abdomen)
Abdominal Surgery
Pediatric patients presenting for elective abdominal surgery at Boston Children's Hospital
Other: Surgical Site Infection
infection at the site of the surgery (spine or abdomen)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00037804

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgical Site Infection

Clinical Trials on Surgical Site Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe