Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures

The purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.

Study Overview

• Status: Terminated
• Conditions: Surgical Wound Infection; Fractures, Open
• Intervention / Treatment: Drug: Vancomycin

Detailed Description

Hypothesis:

Local administration of 1 gram of vancomycin powder at the site of primarily closeable Gustilo-Anderson Grade I-IIIA open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm.

Methods:

Study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). Each group will have an equal number of subjects. Once randomized, the intervention is then un-blinded to facilitate treatment.

Post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. The surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. Patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. There will be no additional appointments solely for the purpose of research follow-up.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Skeletally mature patients ≥18 years of age
• Acute Gustilo-Anderson Type I-IIIA open fracture
• Fracture is deemed primarily closable at initial surgery
• Likely to follow-up with surgeon until fracture is healed
• Ability to understand and agree to Informed Consent

Exclusion Criteria:

• Patients <18 years of age
• Gustilo-Anderson Type IIIB and IIIC open fractures
• Open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects)
• Delayed presentation of open fracture
• Pre-existing systemic infection requiring antibiotic therapy
• Allergy to Vancomycin
• Open fracture at the site of a previous fracture or surgical site
• Current skin infection, chronic wounds or known systemic infection
• Unlikely to follow-up until fracture is healed
• Unable to understand or agree to Informed Consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vancomycin Powder; If the patient randomizes to the experimental group (vancomycin powder), the patient will receive open fracture care identical to the control group except that, prior to closure, 1 gram of vancomycin powder will be applied locally to the open fracture bed. The traumatic and surgical wounds will be closed over a sterile drain and dressed, and the extremity will be immobilized.	Drug: Vancomycin; Vancomycin powder administered locally, intraoperatively at site of open fracture
No Intervention: Standard Treatment; If the patient randomizes to the control group (standard treatment), the patient will receive irrigation and debridement of the fracture site and surrounding soft tissues. The fracture will then be stabilized in standard fashion determined by fracture personality. Once stabilized, a sterile drain will be placed in the open fracture bed and the traumatic and surgical wounds will be closed and dressed. The extremity will then be immobilized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Infection	Infections will be considered clinically significant if they require a return to the operating suite for surgical debridement. These infections will be classified as acute infections and/or chronic osteomyelitis. Superficial skin infections will be treated with local wound care, oral antibiotics and incision and drainage (as indicated). Deep infections and chronic osteomyelitis will be treated with staged serial surgical debridement, hardware removal (as indicated), culture specific IV antibiotics, and Infectious Disease consultation.	one year

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Dirk W Kiner, MD, University of Tennessee College of Medicine Chattanooga/Erlanger Health System

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Vancomycin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Fractures, Bone; Surgical Wound; Surgical Wound Infection; Wound Infection; Fractures, Open; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 13-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No