Surgical Site InfectionNCT04773457
Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients
An observational study of Surgical Site Infection, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 months to 19 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Surgical Site Infection
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients presenting for elective surgical procedures (open gastrointestinal surgery or spine fusion surgery) at Boston Children's Hospital.
Who may be able to join
- scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery
Who cannot join
- On chronic immunosuppressive drugs such as chronic corticosteroid use
- preexisting immunodeficiency diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hopsital
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Surgical Site Infection
- Being tested
- Surgical Site Infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Site InfectionOther
infection at the site of the surgery (spine or abdomen)
| Study group | Role | What they receive |
|---|---|---|
| Spine Surgery | Pediatric patients presenting for elective spine fusion surgery at Boston Children's Hospital Receives: Other: Surgical Site Infection | |
| Abdominal Surgery | Pediatric patients presenting for elective abdominal surgery at Boston Children's Hospital Receives: Other: Surgical Site Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil populations
compare neutrophil population between patients with SSI and without SSI by delineating transcriptomic profiles
Measured: 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
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichi Yuki, Boston Children's Hospital
- Investigators
- Koichi Yuki, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773457
- Sponsor's protocol ID
- IRB-P00037804
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2021
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients
- ClinicalTrials.gov ID
- NCT04773457
- Acronym / sponsor ID
- IRB-P00037804
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spine Surgery | – | Other: Surgical Site InfectionPediatric patients presenting for elective spine fusion surgery at Boston Children's Hospital |
| Abdominal Surgery | – | Other: Surgical Site InfectionPediatric patients presenting for elective abdominal surgery at Boston Children's Hospital |
Who may qualify
- Ages
- 12 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients presenting for elective surgical procedures (open gastrointestinal surgery or spine fusion surgery) at Boston Children's Hospital.
Key inclusion criteria (1 listed)
- scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery
Key exclusion criteria (2 listed)
- On chronic immunosuppressive drugs such as chronic corticosteroid use
- preexisting immunodeficiency diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Site Infectioninfection at the site of the surgery (spine or abdomen) | Other | Abdominal Surgery, Spine Surgery |
Primary outcome
Neutrophil populations
Time frame: up to 3 days
compare neutrophil population between patients with SSI and without SSI by delineating transcriptomic profiles
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koichi Yuki, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil populations (time frame: up to 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.