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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03785834
Enrollment
56
Registered
2018-12-24
Start date
2018-05-25
Completion date
2024-12-31
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cellulitis, Pseudocellulitis

Brief 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.

Interventions

PROCEDUREPunch Biopsy

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

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
The feasibility of conducting a larger study will be conducted, by establishing patient enrollment ratesAt study completion, around 2 years after study startAccording 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.

Secondary

MeasureTime frameDescription
Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations1 yearCellulitis 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
The rate of participant readmission within 30 days1 yearThe investigators will examine 30 day readmission rates between standard care and interventional care
Length of hospitalization as measured in days1 yearThe investigators will examine hospital length-of-stay in patients randomized to interventional vs standard care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026