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

NCT02400112 | Terminated Phase 4

• 1 other identifier: 13-111
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Open; Surgical Wound Infection

Keywords

Vancomycin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vancomycin Powder

EXPERIMENTAL

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

Standard Treatment

NO INTERVENTION

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.

Interventions

Vancomycin DRUG

Vancomycin powder administered locally, intraoperatively at site of open fracture

Vancomycin Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Fractures, Open; Surgical Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dirk W Kiner, MD

  University of Tennessee College of Medicine Chattanooga/Erlanger Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)