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Clinical Trials/NCT03785834
NCT03785834
Completed
Not Applicable

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

Ohio State University1 site in 1 country56 target enrollmentMay 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cellulitis
Sponsor
Ohio State University
Enrollment
56
Locations
1
Primary Endpoint
The feasibility of conducting a larger study will be conducted, by establishing patient enrollment rates
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2018
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ben H Kaffenberger

Associate Professor-Clinical Dermatology

Ohio State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations(1 year)
  • The rate of participant readmission within 30 days(1 year)
  • Length of hospitalization as measured in days(1 year)

Study Sites (1)

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