NCT01773499

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

January 17, 2013

Last Update Submit

March 18, 2015

Conditions

Cellulitis

Keywords

cellulitisultrasound

Outcome Measures

Primary Outcomes (1)

  • Failure of therapy

    Patients with change in antibiotics or hospital admission

    7 days

Study Arms (1)

Patient with Cellulitis

Patients with uncomplicated cellulitis treated as outpatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Cellulitis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Romolo J Gaspari, MD, PhD

    UMass Memorial Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 23, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

US(1)