NCT04773457

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Feb 2024

Typical duration 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 Progress80%
Feb 2024Dec 2026

First Submitted

Initial submission to the registry

February 12, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
2.9 years until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 12, 2021

Last Update Submit

March 16, 2026

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (2)

  • Neutrophil populations

    compare neutrophil population between patients with SSI and without SSI by delineating transcriptomic profiles

    up to 3 days

  • 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

Study Arms (2)

Spine Surgery

Pediatric patients presenting for elective spine fusion surgery at Boston Children's Hospital

Other: Surgical Site Infection

Abdominal Surgery

Pediatric patients presenting for elective abdominal surgery at Boston Children's Hospital

Other: Surgical Site Infection

Interventions

Surgical Site InfectionOTHER

infection at the site of the surgery (spine or abdomen)

Abdominal SurgerySpine Surgery

Eligibility Criteria

Age12 Months - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery

You may not qualify if:

  • On chronic immunosuppressive drugs such as chronic corticosteroid use
  • preexisting immunodeficiency diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Koichi Yuki, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 26, 2021

Study Start

February 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

US(1)