Clinical trial NCT03785834: The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis
Official title: The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cellulitis
Pseudocellulitis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's ages 18 to 99 years that present in the ED with pseudocellulitis or cellulitis.

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.


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

Primary outcomes:
measure: The feasibility of conducting a larger study will be conducted, by establishing patient enrollment rates
timeFrame: At study completion, around 2 years after study start
Secondary outcomes:
measure: Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations
timeFrame: 1 year
measure: The rate of participant readmission within 30 days
timeFrame: 1 year
measure: Length of hospitalization as measured in days
timeFrame: 1 year
Other outcomes:
Locations:
city: Gahanna
country: United States
facility: The Ohio State University Dermatology
state: Ohio
Study officials:
affiliation: Ohio State University
name: Benhamin Kaffenberger, MD
role: PRINCIPAL_INVESTIGATOR
References: