Soft Tissue InfectionsPhase 1NCT01557426
Soft Tissue Ultrasound of Infections
A Phase 1 study testing Ultrasound in people with Soft Tissue Infections and Cellulitis, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Objectives: This study aims to characterize severe skin and soft tissue infections (SSTIs) in the emergency department through the acquisition of ultrasound images. A wide range of SSTIs will be imaged and recorded, leading to a registry of these infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Infections, Cellulitis, Abscess
- What is being tested?
- Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to understand risks/benefits and consent to participation in the study
- Ability to read and understand English or Spanish
- Primary diagnosis for admission is SSTI, including cellulitis, abscess, fasciitis, myositis
- Requiring admission to an inpatient service
Who cannot join
- Patients in custody of law enforcement
- Patients on a psychiatric hold
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Objectives:
This study aims to characterize severe skin and soft tissue infections (SSTIs) in the emergency department through the acquisition of ultrasound images. A wide range of SSTIs will be imaged and recorded, leading to a registry of these infections. The registry will show whether ED (emergency department) sonographers can accurately characterize these infections, as compared to the final hospital diagnosis. The registry will also provide data for a case-control study comparing ultrasonographic characteristics of necrotizing skin and soft tissue infections (NSTIs) to those of non-necrotizing SSTIs.
Read more
Research procedures:
In this study, the investigators will approach patients who present to the Emergency Department with a possible skin and/or tissue infection. Study subjects must be ED patients requiring admission to the hospital for the primary problem of an SSTI due to the need for follow-up. If the patient consents to participating in the study, the investigator will obtain and record an ultrasound image of the infected area. An ultrasound image of an uninfected area of skin will also be recorded for comparison. Patient information regarding personal history, physical examination, blood tests and x-rays will also be gathered from participants.
- Conditions
- Soft Tissue Infections, Cellulitis, Abscess
- Being tested
- Ultrasound
- Keywords
- skin, soft tissue, infection, cellulitis, abscess
- Medical subject headings
- Soft Tissue Infections, Cellulitis, Abscess, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
A linear ultrasound transducer will be used with ultrasound gel to obtain an image of subcutaneous structures and tissues over the involved body site. Ultrasound video will be recorded whenever possible, however studies that are not recorded will still be included. Video recording will be initiated once the desired image is obtained. Appropriate measurements will be made and views identified using the features of the ultrasound machine. Scanning of the contralateral body segment will then be performed. The ultrasound probe will be thoroughly cleaned and disinfected between ultrasound scans.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Other | Single interventional group - patients agree to an ultrasound of their skin or soft tissue infection and an ultrasound to an uninfected portion of skin. Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge diagnosis
Discharge diagnosis will be collected by retrospective chart review
Measured: 2 years
Secondary outcomes (1)
Disposition after admission
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Otto Liebmann, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557426
- Sponsor's protocol ID
- 304321
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Ultrasound of Infections
- ClinicalTrials.gov ID
- NCT01557426
- Acronym / sponsor ID
- 304321
- Conditions
- Soft Tissue Infections, Cellulitis, Abscess
- Keywords
- skin, soft tissue, infection, cellulitis, abscess
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Mar 2012 (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.
Objectives:
This study aims to characterize severe skin and soft tissue infections (SSTIs) in the emergency department through the acquisition of ultrasound images. A wide range of SSTIs will be imaged and recorded, leading to a registry of these infections. The registry will show whether ED (emergency department) sonographers can accurately characterize these infections, as compared to the final hospital diagnosis. The registry will also provide data for a case-control study comparing ultrasonographic characteristics of necrotizing skin and soft tissue infections (NSTIs) to those of non-necrotizing SSTIs.
Research procedures:
In this study, the investigators will approach patients who present to the Emergency Department with a possible skin and/or tissue infection. Study subjects must be ED patients requiring admission to the hospital for the primary problem of an SSTI due to the need for follow-up. If the patient consents to participating in the study, the investigator will obtain and record an ultrasound image of the infected area. An ultrasound image of an uninfected area of skin will also be recorded for comparison. Patient information regarding personal history, physical examination, blood tests and x-rays will also be gathered from participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Other | Other: UltrasoundSingle interventional group - patients agree to an ultrasound of their skin or soft tissue infection and an ultrasound to an uninfected portion of skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Ability to understand risks/benefits and consent to participation in the study
- Ability to read and understand English or Spanish
- Primary diagnosis for admission is SSTI, including cellulitis, abscess, fasciitis, myositis
- Requiring admission to an inpatient service
Key exclusion criteria (2 listed)
- Patients in custody of law enforcement
- Patients on a psychiatric hold
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 |
|---|---|---|
| UltrasoundA linear ultrasound transducer will be used with ultrasound gel to obtain an image of subcutaneous structures and tissues over the involved body site. Ultrasound video will be recorded whenever possible, however studies that are not recorded will still be included. Video recording will be initiated once the desired image is obtained. Appropriate measurements will be made and views identified using the features of the ultrasound machine. Scanning of the contralateral body segment will then be performed. The ultrasound probe will be thoroughly cleaned and disinfected between ultrasound scans. | Other | Ultrasound |
Primary outcome
Discharge diagnosis
Time frame: 2 years
Discharge diagnosis will be collected by retrospective chart review
1 secondary outcome
Disposition after admission
Time frame: 2 years
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 29 Apr 2015.
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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.
Otto Liebmann, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultrasound in people with Soft Tissue Infections and Cellulitis, run by Rhode Island 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 5 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: finished, as of the sponsor's last update on 29 Apr 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Discharge diagnosis (time frame: 2 years). 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 29 Apr 2015.