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Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER)

Primary Purpose

Open Fracture

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Open Fracture focused on measuring infection, vancomycin, topical antibiotic, antibiotic prophylaxis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
  • Adult 18 years of age or older.
  • Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
  • 24 hours or less has elapsed from the estimated time of injury to study intervention.

Exclusion Criteria:

  • Time from injury > 24 hours.
  • Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
  • Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
  • High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
  • Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
  • Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
  • Prisoners.
  • Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Sites / Locations

  • University HospitalRecruiting
  • San Antonio Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Intervention Arm

Control Arm

Observational Arm

Arm Description

Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.

Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.

Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.

Outcomes

Primary Outcome Measures

Deep-space infection rate at prophylaxis site
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.

Secondary Outcome Measures

Superficial infection rate requiring post-operative medical intervention
The percentage of participants who develop an infection of the study open fracture that requires post-operative medical intervention, including addition or change of antibiotic, bedside application of incision & drainage, needle aspiration, and bedside application of a drain.
Unplanned repeat visit rate
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Readmission rate for open fracture infection
The percentage of participants who are readmitted to the hospital due to infection or complication of the study open fracture. Included in this assessment is sepsis and sepsis-related conditions arising from an open fracture infection.
Death rate
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.

Full Information

First Posted
December 4, 2018
Last Updated
March 2, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
United States Army Institute of Surgical Research, San Antonio Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03765567
Brief Title
Placement of Antibiotic Powder in Wounds During the Emergency Room
Acronym
POWDER
Official Title
Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
United States Army Institute of Surgical Research, San Antonio Military Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.
Detailed Description
Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Fracture
Keywords
infection, vancomycin, topical antibiotic, antibiotic prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder
Intervention Description
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
Primary Outcome Measure Information:
Title
Deep-space infection rate at prophylaxis site
Description
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
Time Frame
Within one year of injury date
Secondary Outcome Measure Information:
Title
Superficial infection rate requiring post-operative medical intervention
Description
The percentage of participants who develop an infection of the study open fracture that requires post-operative medical intervention, including addition or change of antibiotic, bedside application of incision & drainage, needle aspiration, and bedside application of a drain.
Time Frame
Within one year of injury date
Title
Unplanned repeat visit rate
Description
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Time Frame
Within one year of injury date
Title
Readmission rate for open fracture infection
Description
The percentage of participants who are readmitted to the hospital due to infection or complication of the study open fracture. Included in this assessment is sepsis and sepsis-related conditions arising from an open fracture infection.
Time Frame
Within one year of injury date
Title
Death rate
Description
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.
Time Frame
Within one year of injury date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent. Adult 18 years of age or older. Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula. 24 hours or less has elapsed from the estimated time of injury to study intervention. Exclusion Criteria: Time from injury > 24 hours. Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility. Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur). High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted. Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion. Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment. Prisoners. Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert A De Lorenzo, MD
Phone
210-567-0056
Email
DeLorenzo@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A De Lorenzo, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert DeLorenzo, MD
Phone
210-567-4292
Email
delorenzo@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Martinez
Phone
210 450-8566
Email
martinezs13@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Robert A De Lorenzo, MD
Facility Name
San Antonio Military Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven G Schauer, DO
Email
steven.g.schauer.mil@mail.mil
First Name & Middle Initial & Last Name & Degree
Steven G Schauer, DO

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared through the use of the REDCap Web-based distributed data collection system. All sharing of data will conform to currently established DOD HRPO (Department of Defense Human Research Protection Office) human subject protection practices and will be in compliance with all appropriate state and federal confidentiality requirements and privacy guidelines.
IPD Sharing Time Frame
Data will be made available within one year of study completion.
IPD Sharing Access Criteria
Research data obtained through this study will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. While data will be provided in a timely fashion, the actual timelines of availability of requested data will be specific to the data requested and any special sensitivity of the requested data set.

Learn more about this trial

Placement of Antibiotic Powder in Wounds During the Emergency Room

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