A Phase 4 interventional study of Vancomycin in Fractures, Open and Surgical Wound Infection, sponsored by University of Tennessee. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-29.
Sponsored by University of Tennessee · Phase 4, Interventional, and Prevention
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.
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.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's enrollment of 11 is below the median of 90 across 40 interventional studies indexed under Fractures, Open.
Browse Fractures, Open studies →University of Tennessee is the lead sponsor of 142 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Vancomycin powder administered locally, intraoperatively at site of open fracture
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.
Time frame: one year
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2015, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vancomycin