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CompletedNCT03785834Updated Mar 25, 2025

The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis

An observational study in Cellulitis and Pseudocellulitis, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 99 Years
Sex
All
01

Study summary

The Investigators wish to study the value of dermatologic testing assessments in differentiating between cellulitis and pseudocellulitis in the inpatient setting. The Investigators propose that by utilizing cutaneous biopsies and tissue cultures in patients that have been admitted to inpatient internal medicine teams, the investigators may be able to improve multiple measures of hospital efficiency in patients presenting with cellulitis-like symptoms, by more accurately recognizing cellulitis from pseudocellulitis. The patient will undergo encrypted digital imaging for his or her condition. This image will then be sent to the study investigators, along with basic clinical information on the skin evaluation form. The study investigators will develop a differential diagnosis and then the patient will undergo a skin biopsy. The patient will then be randomized to one of two arms using a random number generator: A) Skin biopsies and tissue cultures recorded and published in patient's medical chart as they would be in a standard of care procedure B) Skin biopsies and tissue cultures consultation performed but not published in the patient's medical chart unless medically necessary. Information will be collected from medical records in IHIS. Patients will be contacted by phone 30 days after discharge.

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Conditions studied

  • Cellulitis
  • Pseudocellulitis

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03

In context

Cellulitis

160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.

This study's enrollment of 56 is below the median of 208 across 29 observational studies indexed under Cellulitis.

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Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient's ages 18 to 99 years that present in the ED with pseudocellulitis or cellulitis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • admitted inpatient to The Ohio State University Wexner Medical Center Internal Medicine ward with cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion.
  • Affecting one or more extremities
  • are at least 90 days post any associated operation of the extremity
  • are above the age of 18
  • Participants will be patients with cellulitis or pseudocellulitis.
  • Patients who have recurrent cellulitis will be eligible for enrollment into the study, but only once.

Exclusion criteria

Exclusion Criteria:

  • Patients who are pregnant
  • Prisoners
  • Patients may not have trauma, ulcer, or puncture wound to the area
  • May not be transferred from another hospital
  • May not be admitted to the Cancer Hospital or with a known active solid organ or hematologic cancer other than nonmelanoma skin cancer
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (actual)
Patient registry
No

Interventions

  • ProcedurePunch Biopsy

    The patient will undergo two 6 mm punch biopsies into the affected extremity at the most proximal portion of the redness.

06

What researchers measure

Primary outcomes

  1. The feasibility of conducting a larger study will be conducted, by establishing patient enrollment rates

    According to the NIH: The goal of pilot work is not to test hypotheses about the effects of an intervention, but rather, to assess the feasibility/acceptability of an approach to be used in a larger scale study. We will use descriptive statistics to monitor patient enrollment and pilot data on additional secondary outcomes for inferential statistics.

    Time frame: At study completion, around 2 years after study start

Secondary outcomes

  1. Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations

    Cellulitis is a common type of bacterial skin infection. Pseudocellulitis is a skin infection that is very similar to cellulitis and is often misdiagnosed as cellulitis

    Time frame: 1 year

  2. The rate of participant readmission within 30 days

    The investigators will examine 30 day readmission rates between standard care and interventional care

    Time frame: 1 year

  3. Length of hospitalization as measured in days

    The investigators will examine hospital length-of-stay in patients randomized to interventional vs standard care

    Time frame: 1 year

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Study locations

1 site
  • The Ohio State University Dermatology
    Gahanna, Ohio 43230, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Jun 2024, 72 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2018
First posted
Dec 24, 2018
StartActual
May 25, 2018
Primary completionActual
Jun 1, 2024
CompletionActual
Dec 31, 2024
Last update
Mar 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03785834
Responsible party
Ben H Kaffenberger (Associate Professor-Clinical Dermatology, Ohio State University) — Principal investigator
First posted
Dec 24, 2018
Start date
May 25, 2018
Primary completion
Jun 1, 2024
Completion
Dec 31, 2024
Last update
Mar 25, 2025

Study contacts

Benhamin Kaffenberger, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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