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

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ClinicalTrials.gov Identifier: NCT02400112
Recruitment Status : Terminated (Low enrollment; Low clinical relevance: evidence for use of vancomycin powder)
First Posted : March 26, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fractures, Open Surgical Wound Infection Drug: Vancomycin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
Study Start Date : March 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.



Primary Outcome Measures :
  1. Postoperative Infection [ Time Frame: one year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400112


Locations
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United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Dirk W Kiner, MD University of Tennessee College of Medicine Chattanooga/Erlanger Health System

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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02400112     History of Changes
Other Study ID Numbers: 13-111
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Tennessee:
Vancomycin
Additional relevant MeSH terms:
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Vancomycin
Wound Infection
Surgical Wound Infection
Fractures, Bone
Surgical Wound
Fractures, Open
Wounds and Injuries
Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents