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

NCT03785834 | Completed

• 1 other identifier: 2018H0147
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis; Pseudocellulitis

Outcome Measures

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.

  At study completion, around 2 years after study start

Secondary Outcomes (3)

• 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

Interventions

Punch Biopsy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Dermatology

Gahanna, Ohio, 43230, United States

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benhamin Kaffenberger, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Clinical Dermatology

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 24, 2018
• Study Start: May 25, 2018
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)