NCT02948387

Brief Summary

Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 14, 2016

Last Update Submit

October 26, 2016

Conditions

Open Fracture

Outcome Measures

Primary Outcomes (1)

  • Rate of fracture site infections

    number of infections

    30 days

Secondary Outcomes (4)

  • Incidence of acute renal injury

    30 days

  • type of bacteria infection

    30 days

  • resistance trend in patients with infections

    30 days

  • number of secondary infections at site other than fracture sites

    30 days

Eligibility Criteria

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

Patients who are at least 18 years of age with Type II or III open fractures

You may qualify if:

  • Male or Female \>= 18 years old
  • Patients are diagnosed with a Type II or III open fracture

You may not qualify if:

  • Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
  • pregnancy
  • did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
  • receiving ongoing inpatient care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Triple O Research Institute PA

West Palm Beach, Florida, 33401, United States

Location

MeSH Terms

Conditions

Fractures, Open

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Olayemi Osiyemi, MD

    Triple O Research Institute PA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Glickman

CONTACT

561-855-7871pglickmn@tripleoresearch.com

Olayemi Osiyemi, MD

CONTACT

561-855-7871drtripleo@tripleoresearch.com

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 28, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

February 1, 2018

Last Updated

October 28, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)