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Status unknownNCT02948387Updated Oct 28, 2016

Preventing Infections in Orthopaedic Patients

An observational study in Open Fracture, sponsored by Olayemi Osiyemi MD. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Olayemi Osiyemi MD · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description
  1. Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
  2. Identify the incidence of acute kidney injury.
  3. Identify the type and number of associated infections
  4. Identify the antibiotic resistance profile noted
  5. Identify any secondary infections at sites other than the fracture site
02

Conditions studied

  • Open Fracture

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03

In context

Fractures, Open

53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.

This study's planned enrollment of 50 is below the median of 93 across 13 observational studies indexed under Fractures, Open.

Browse Fractures, Open studies →

Lead sponsor

Olayemi Osiyemi MD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of fracture site infections

    number of infections

    Time frame: 30 days

Secondary outcomes

  1. Incidence of acute renal injury

    number of patients with worsening renal function from baseline

    Time frame: 30 days

  2. type of bacteria infection

    name of bacteria infection

    Time frame: 30 days

  3. resistance trend in patients with infections

    describe the number of MDRO infections

    Time frame: 30 days

  4. number of secondary infections at site other than fracture sites

    describe the number infections at secondary sites

    Time frame: 30 days

07

Study locations

1 site
  • Triple O Research Institute PA
    West Palm Beach, Florida 33401, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02948387
Lead sponsor
Olayemi Osiyemi MD
Collaborators
Forest Laboratories
Responsible party
Olayemi Osiyemi MD (President, Triple O Research Institute PA) — Sponsor-investigator
First posted
Oct 28, 2016
Start date
Nov 2016
Primary completion
Oct 2017 (estimated)
Completion
Feb 2018 (estimated)
Last update
Oct 28, 2016

Study contacts

Paul Glickman
Contact
pglickmn@tripleoresearch.com
561-855-7871
Olayemi Osiyemi, MD
Contact
drtripleo@tripleoresearch.com
561-855-7871
Olayemi Osiyemi, MD
principal investigator · Triple O Research Institute PA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Olayemi Osiyemi MD

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