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Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Primary Purpose

Fractures, Open

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tobramycin
Placebo: normal saline
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Open

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Virginia Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Antibiotic

Normal Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
May 18, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03705962
Brief Title
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
Official Title
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to continue study due to funding and personnel restraints
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Open

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Type
Other
Intervention Name(s)
Placebo: normal saline
Primary Outcome Measure Information:
Title
Presence of Wound Infection
Description
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
Time Frame
6 weeks post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Yarboro, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

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