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Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

Primary Purpose

Post Operative Surgical Site Infection

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Treatment group

Control group

About this trial

This is an interventional treatment trial for Post Operative Surgical Site Infection focused on measuring Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection:
1. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.
2. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds.
Patients ages 18 through 80 years.

Exclusion Criteria:

Study injury is already infected at time of study enrollment.
Definitive fixation of the study injury prior to enrollment in the study.
The patient never receives study fixation.
Massive myonecrosis from ipsilateral leg compartment syndrome.
Currently pregnant.
Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information).
Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.

Sites / Locations

University of Maryland Shock Trauma CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.

Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.

Outcomes

Primary Outcome Measures

Deep Surgical Site Infection (SSI)

Compare the proportion of deep SSIs of the study injury within 365 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders. For this study a "deep SSI" is a SSI that is treated with operative debridement. In the current CDC terminology this would include all deep organ space, deep incisional, and superficial infections that are treated with surgery.

Secondary Outcome Measures

Sensitivity analyses

These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections.

Antibiotic resistance

To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.

Full Information

NCT ID

NCT04597008

First Posted

October 15, 2020

Last Updated

August 2, 2023

Sponsor

Major Extremity Trauma Research Consortium

1. Study Identification

Unique Protocol Identification Number

NCT04597008

Brief Title

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

Official Title

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 11, 2021 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Major Extremity Trauma Research Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

Detailed Description

Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 365 days of definitive fracture fixation surgery in patients allocated to receive a combination of local Vancomycin and Tobramycin powders compared to patients allocated to local Vancomycin powder. Sensitivity Analyses: A series of sensitivity analyses will be conducted to look at alternative measures of deep SSI under Specific Aim 1. These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections. Specific Aim 2: To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.

6. Conditions and Keywords

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

Post Operative Surgical Site Infection

Keywords

Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Treatment group

Other Intervention Name(s)

Treatment

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Control group

Other Intervention Name(s)

Control

Intervention Description

Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.

Primary Outcome Measure Information:

Title

Deep Surgical Site Infection (SSI)

Description

Time Frame

within 365 days of definitive fracture fixation surgery

Secondary Outcome Measure Information:

Title

Sensitivity analyses

Description

Time Frame

within 365 days of definitive fracture fixation surgery

Title

Antibiotic resistance

Description

To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.

Time Frame

within 365 days of definitive fracture fixation surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection: Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds. Patients ages 18 through 80 years. Exclusion Criteria: Study injury is already infected at time of study enrollment. Definitive fixation of the study injury prior to enrollment in the study. The patient never receives study fixation. Massive myonecrosis from ipsilateral leg compartment syndrome. Currently pregnant. Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information). Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome). Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suna Chung, MPH

Phone

410-502-3357

schung60@jhu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Susan C Collins, MSc

Phone

410-502-8966

scolli21@jhu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert V O'Toole, MD, MS

Organizational Affiliation

University of Maryland, Department of Orthopaedic Trauma

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Renan C Castillo, PhD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anthony R Carlini, MS

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Study Director

Facility Information:

Facility Name

University of Maryland Shock Trauma Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert O'Toole

12. IPD Sharing Statement

Learn more about this trial

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

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