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OpenTrials
Completed

NCT Number: NCT03785834

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

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Dermatology

Gahanna, Ohio, 43230, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Punch Biopsy

Procedure

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

Primary outcomes

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

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

    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.

Secondary outcomes

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

    Time frame: 1 year

    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

  2. The rate of participant readmission within 30 days

    Time frame: 1 year

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

  3. Length of hospitalization as measured in days

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2018
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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