Preventing Infections in Orthopaedic Patients | NCT02948387

Studies
Preventing Infections in Orthopaedic Patients

NCT02948387

Sponsor

Olayemi Osiyemi MD

Status

Unknown status

Last Update Posted

Oct 28, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Open Fracture

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Oct 14, 2016

First Submission Date that Met QC Criteria

Oct 26, 2016

First Posted Date

Oct 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of fracture site infections	number of infections	30 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of acute renal injury	number of patients with worsening renal function from baseline	30 days
type of bacteria infection	name of bacteria infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul Glickman	Contact	561-855-7871		pglickmn@tripleoresearch.com
Olayemi Osiyemi, MD	Contact	561-855-7871		drtripleo@tripleoresearch.com

Overall Officials

Name	Affiliation	Role
Olayemi Osiyemi, MD	Triple O Research Institute PA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Triple O Research Institute PA		West Palm Beach	Florida	33401	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005597	Fractures, Open

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided