CellulitisNCT03034694
The Effect of Dermatology and Teledermatology Consultations on Length of Hospital Admission, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Inpatient Setting
A study testing teledermatology consult and Routine Care in people with Cellulitis, run by Ohio State University at 1 site in United States.
Trial summary
The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cellulitis
- What is being tested?
- teledermatology consult and Routine Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18
- Admission for cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion
Who cannot join
- pregnant
- prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.
- Conditions
- Cellulitis
- Being tested
- teledermatology consult, Routine Care
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teledermatology consultOther
teledermatology consult
Routine CareOther
The patient will undergo imaging but this report will not be put into the chart.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | Placebo comparator | The first group will be randomized to routine care of receiving or not receiving a dermatology consult in the hospitalized setting based on the clinical decision of the hospitalist. The patients will see the research coordinator who will take images and for a teledermatology assessment, however, these assessments will not be placed in the chart and the treating hospitalist will not know. Receives: Other: Routine Care |
| Teledermatology INtervention | Experimental | The second arm will be patient randomized to teledermatology intervention. These patients will be imaged by the research coordinator, then the assessment will be placed in the chart for the hospitalist to see although final treatment decisions are still made by the hospitalist. Receives: Other: teledermatology consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization
Measured: 60 Days
Secondary outcomes (2)
Readmission rate
Measured: 30 Days
Frequency/Use of antibiotics
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CellulitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Routine Care vs The use of teledermatology
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Kaffenberger, Ohio State University
- Investigators
- Benjamin H Kaffenberger, MD, Principal investigator, OSU Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034694
- Sponsor's protocol ID
- 2015H0393
- Status last verified
- Jan 2018
- First submitted
- 4 Jun 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dermatology and Teledermatology Consultations on Length of Hospital Admission, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Inpatient Setting
- ClinicalTrials.gov ID
- NCT03034694
- Acronym / sponsor ID
- 2015H0393
- Conditions
- Cellulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 27 Jan 2017 (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.
The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Routine Care vs The use of teledermatology
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Placebo comparator | Other: Routine CareThe first group will be randomized to routine care of receiving or not receiving a dermatology consult in the hospitalized setting based on the clinical decision of the hospitalist. The patients will see the research coordinator who will take images and for a teledermatology assessment, however, these assessments will not be placed in the chart and the treating hospitalist will not know. |
| Teledermatology INtervention | Experimental | Other: teledermatology consultThe second arm will be patient randomized to teledermatology intervention. These patients will be imaged by the research coordinator, then the assessment will be placed in the chart for the hospitalist to see although final treatment decisions are still made by the hospitalist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18
- Admission for cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion
Key exclusion criteria (2 listed)
- pregnant
- prisoner
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 |
|---|---|---|
| teledermatology consultteledermatology consult | Other | Teledermatology INtervention |
| Routine CareThe patient will undergo imaging but this report will not be put into the chart. | Other | Routine Care |
Primary outcome
Length of Hospitalization
Time frame: 60 Days
2 secondary outcomes
Readmission rate
Time frame: 30 Days
Frequency/Use of antibiotics
Time frame: 30 days
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 18 Jan 2018.
- Individual participant dataSharing planned: Yes
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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.
Benjamin H Kaffenberger, MD principal investigator
OSU Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing teledermatology consult and Routine Care in people with Cellulitis, run by Ohio State University 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 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 18 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Length of Hospitalization (time frame: 60 Days). 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 18 Jan 2018.