NCT03705962

Brief Summary

The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2015

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2019

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

May 1, 2023

Enrollment Period

3.7 years

First QC Date

May 12, 2016

Results QC Date

May 18, 2023

Last Update Submit

May 18, 2023

Conditions

Fractures, Open

Outcome Measures

Primary Outcomes (1)

  • Presence of Wound Infection

    Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics

    6 weeks post op

Study Arms (2)

Antibiotic

EXPERIMENTAL

Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.

Drug: Tobramycin

Normal Saline

PLACEBO COMPARATOR

Subjects will be injected locally with 40 mL 0.9% NS after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.

Other: Placebo: normal saline

Interventions

TobramycinDRUG
Antibiotic
Placebo: normal salineOTHER
Normal Saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 - 70 years
  • Gustilo Type I,II,IIIa open fracture (s)
  • Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
  • Subject should be able to follow up at the scheduled times following surgery
  • Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study

You may not qualify if:

  • Closed fracture
  • Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
  • Aminoglycoside allergy
  • Presentation greater than 48 hours after injury
  • Pathologic fracture
  • Preexisting infection in bone with an open fracture
  • Patients with multiple trauma involving liver, kidney, or brain
  • Pregnancy (self-reported)
  • Current status as prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Fractures, Open

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydrates

Limitations and Caveats

We were not able to enroll our goal of 120 patients; therefore, there is an insufficient sample size to perform any statistical test to evaluate the effect of early tobramycin in this study.

Results Point of Contact

Title
Eric McVey
Organization
University of Virginia
edm9u@hscmail.mcc.virginia.edu
434.243.5382

Study Officials

  • Seth Yarboro, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Orthopaedic Surgery

Study Record Dates

First Submitted

May 12, 2016

First Posted

October 15, 2018

Study Start

July 1, 2015

Primary Completion

March 7, 2019

Study Completion

March 7, 2019

Last Updated

June 15, 2023

Results First Posted

June 15, 2023

Record last verified: 2023-05

Locations

US(1)