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

NCT ID: NCT03785834

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Punch Biopsy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Ben H Kaffenberger

Associate Professor-Clinical Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benhamin Kaffenberger, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Dermatology

Gahanna, Ohio, United States

Countries

United States

Other Identifiers

2018H0147

Identifier Type: -

Identifier Source: org_study_id