NCT00822692

Brief Summary

Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 3, 2009

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

January 13, 2009

Results QC Date

July 29, 2009

Last Update Submit

December 17, 2015

Conditions

AbscessMethicillin-Resistant Staphylococcus Aureus Infection

Keywords

AbscessCellulitisAntibioticsMRSA

Outcome Measures

Primary Outcomes (1)

  • Recurrence Rates of Abscesses

    Number of patient with a new abscess in same or different location as previous lesion

    30 days after incision and drainage

Study Arms (2)

Bactrim DS

ACTIVE COMPARATOR

Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days

Drug: Trim/ Sulfa DS

matched placebo

PLACEBO COMPARATOR

matched placebo 2 pills orally (PO) twice a day (BID) x 7 days

Drug: placebo

Interventions

Trim/ Sulfa DSDRUG

bactrim DS (800/160) two tablets PO BID x 7 days

Also known as: Bactrim
Bactrim DS
placeboDRUG

matched placebo 2 pills PO BID x 7 days

matched placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.

You may not qualify if:

  • Patients with diabetes, HIV, cancer or other immunocompromised patients.
  • Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
  • Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
  • Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
  • Finally, patients with sulfa allergy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (1)

  • Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.

    PMID: 20346539DERIVED

MeSH Terms

Conditions

AbscessCellulitis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

SuppurationInfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsSkin Diseases, InfectiousConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Gillian Schmitz, MD
Organization
Wilford Hall Medical Center
gillianmd@gmail.com
919-724-9185

Study Officials

  • Gillian R Schmitz

    59th Medical Wing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Physician

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 21, 2015

Results First Posted

September 3, 2009

Record last verified: 2015-12

Locations

US(1)