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The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Experimental | Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. |
|
| Saline | Placebo Comparator | Subjects in the saline group will receive a Saline injection directly into the wound pocket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infection That Requires Removal of the Neurosurgical Device | The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics. | Six months post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim J Burchiel, MD | Department of Neurological Surgery, Oregon Health & Science University | Principal Investigator |
| Valerie C Anderson, PhD, MCR | Department of Neurological Surgery, Oregon Health & Science University | Principal Investigator |
| Stephen T Magill, PhD | School of Medicine, Oregon Health & Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19263587 | Background | Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. doi: 10.3171/2008.6.17605. |
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214 subjects signed consent. 198 subjects were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin | Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure. |
| FG001 | Saline | Subjects in the saline group will receive a Saline injection directly into the wound pocket. Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin | Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Least Squares Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Infection That Requires Removal of the Neurosurgical Device | The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics. | Posted | Count of Participants | Participants | Six months post-operation |
|
6 months
The study aimed to determine whether retrospectively observed decrease in infection rate could be attributed to the addition of local antibiotics A prospective, randomized, double-blind, placebo-controlled pilot study comparing standard antibiotic prophylaxis with addition of local intrawound injection of vancomycin or placebo, was designed.
Study Procedures were standard of care, risk was minimal
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vancomycin | Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. Vancomycin: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Surgical and medical procedures | Non-systematic Assessment | Wound Infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Oregon Health & Science University | 503-494-4314 | nsgclinicalresearch@ohsu.edu |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Placebo (Saline Solution) | Drug | Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure. |
|
| Saline |
Subjects in the saline group will receive a Saline injection directly into the wound pocket. Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure. |
| BG002 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Saline | Subjects in the saline group will receive a Saline injection directly into the wound pocket. Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure. |
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 2 |
| 98 |
| EG001 | Saline | Subjects in the saline group will receive a Saline injection directly into the wound pocket. Placebo (Saline Solution): Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure. | 0 | 100 | 0 | 100 | 5 | 100 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |