The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis … (NCT03785834) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis
United States56 participantsStarted 2018-05-25
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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