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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02400112
• Other study ID #: 13-111
• Status: Terminated
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: October 2018

Study information

• Verified date: November 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Vancomycin
Vancomycin powder administered locally, intraoperatively at site of open fracture

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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