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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03785834
Other study ID # 2018H0147
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 25, 2018
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The Ohio State University Dermatology Gahanna Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in antibiotic use (antibiotics/day administered) over the course of the hospitalizations 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 1 year
Secondary The rate of participant readmission within 30 days The investigators will examine 30 day readmission rates between standard care and interventional care 1 year
Secondary Length of hospitalization as measured in days The investigators will examine hospital length-of-stay in patients randomized to interventional vs standard care 1 year
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