Sonographic Features of Cellulitis and Failure of Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Skin and soft tissue infections represent a tremendous burden to the health care community with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in 2005. A Cochrane review of cellulitis found that there is limited data to support any specific antibiotic or even a specific length of antibiotic therapy, and that outpatient therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility in differentiating cellulitis from abscess but its role in patients with cellulitis is not well developed. Although speculative, the investigators hypothesize that sonographic features of cellulitis are associated with clinical improvement and successful therapy following antibiotics for patients with cellulitis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study

NCT05023200

Cellulitis Cellulitis of Leg Antibiotic Duration

COMPLETED

Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess

NCT01498744

Abscess Soft Tissue Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Skin Abscess

TERMINATED NA

RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg

NCT00552799

Cellulitis/Erysipelas of the Leg

COMPLETED PHASE4

18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia

NCT05361135

Staphylococcus Aureus Bacteremia Staphylococcus Aureus Septicemia Sepsis Bacterial +4 more

NOT_YET_RECRUITING NA

Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection

NCT03419221

Staphylococcus Aureus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to determine if changes in the sonographic features of cellulitis are associated with failure of therapy. Patients with cellulitis treated in the ED with either intravenous or oral antibiotics will undergo imaging using a standardized ultrasound protocol. Patients will be screened and enrolled in the ED at the UMASS Memorial Medical Center. The study design is single center prospective observational trial involving adult patients with clinical signs of cellulitis requiring antibiotics but not admitted to the hospital. Patients will be imaged upon initial presentation to the ED. Patients discharged from the ED after the initial visit will return to the ED in 24 to 48 hours for a reassessment. Patients kept in the ED under observational status will undergo an identical reassessment. Clinical staff blinded to the ultrasound results will characterize patients as improving, no change or worsening based on progression of the erythema despite antibiotics or change in clinical status. Researchers blinded to the clinical data will review the ultrasound images to quantify the extent of the sonographic evidence of cellulitis compared to the extent of the erythema by physical exam findings.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cellulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with Cellulitis

Patients with uncomplicated cellulitis treated as outpatients

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years or older Symptoms of cellulitis (localized warmth, erythema, swelling or tenderness)

Exclusion Criteria

Admitted for inpatient antibiotics Unable to consent Septic appearing crepitus on exam animal bite soft tissue abscess osteomylitis cellulitis requiring surgical debridement

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No