Soft Tissue InfectionNCT02099227
Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections
An observational study of Soft Tissue Infection, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome. Read more about this study
- Who is it for?
- Ages 6 months to 19 years
- Conditions the study is for
- Soft Tissue Infection
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children presenting to participating pediatric emergency departments
Who may be able to join
- history and examination findings consistent with possible abscess or cellulitis per the treating clinician.
- minimal lesion diameter for inclusion is 1cm.
Who cannot join
- suspected soft tissue infections involving or near mucosal membranes (e.g. perirectal, peritonsillar, vulvovaginal areas)
- facial lesions
- paronychia or felon
- parent or patient refusal of consent
- unsuitable subjects deemed by treating clinicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
About this study
To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome.
- Conditions
- Soft Tissue Infection
- Keywords
- pediatric, soft tissue infections, ultrasonography, effectiveness
- Medical subject headings
- Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | those who received point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections | |
| No Ultrasound | those who did not receive point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure rate
unscheduled return visits need for subsequent procedural intervention need for subsequent admission change in therapy
Measured: 7-10days
Secondary outcomes (1)
emergency department process outcome
emergency department (ED) length of stay, need for ED procedural sedation use of alternative imaging in ED
Measured: 7-10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InfectionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Emergency Physicians, Newark Beth Israel Medical Center, Baylor College of Medicine, UCSF Benioff Children's Hospital Oakland, Maimonides Medical Center, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Samuel Lam, MD, Principal investigator, advocate christ medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099227
- Sponsor's protocol ID
- AHC IRB 5577
- Status last verified
- Sep 2016
- First submitted
- 26 Mar 2014
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT02099227
- Acronym / sponsor ID
- AHC IRB 5577
- Conditions
- Soft Tissue Infection
- Keywords
- pediatric, soft tissue infections, ultrasonography, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American College of Emergency Physicians, Newark Beth Israel Medical Center, Baylor College of Medicine, UCSF Benioff Children's Hospital Oakland, Maimonides Medical Center, Montefiore Medical Center
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- 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.
To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | –those who received point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections |
| No Ultrasound | – | –those who did not receive point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections |
Who may qualify
- Ages
- 6 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children presenting to participating pediatric emergency departments
Key inclusion criteria (2 listed)
- history and examination findings consistent with possible abscess or cellulitis per the treating clinician.
- minimal lesion diameter for inclusion is 1cm.
Key exclusion criteria (5 listed)
- suspected soft tissue infections involving or near mucosal membranes (e.g. perirectal, peritonsillar, vulvovaginal areas)
- facial lesions
- paronychia or felon
- parent or patient refusal of consent
- unsuitable subjects deemed by treating clinicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
treatment failure rate
Time frame: 7-10days
unscheduled return visits need for subsequent procedural intervention need for subsequent admission change in therapy
1 secondary outcome
emergency department process outcome
Time frame: 7-10days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Naproxen Versus Placebo as Adjunct Treatment of Cellulitis
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Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
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Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
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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.
Samuel Lam, MD principal investigator
advocate christ medical center
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 Soft Tissue Infection, run by Wake Forest University Health Sciences 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 4 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
treatment failure rate (time frame: 7-10days). 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 4 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.