Surgical Wound Infections
Conditions
Keywords
Infection, Vancomycin, Neurosurgery, Stimulator, Pump, Deep Brain Stimulation, Intrathecal Pump
Brief summary
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.
Interventions
DRUGVancomycin
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.
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.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* deep brain stimulators (DBS) * spinal cord stimulators (SCS) * motor cortex stimulators (MCS) * vagus nerve stimulators (VNS) * peripheral nerve stimulators (PNS)
Exclusion criteria
* allergies to vancomycin * immunocompromise or taking immunosuppressant drugs * currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin * diagnosed renal failure * currently undergoing chemotherapy * pregnancy * non-english speakers * unable to return for follow-up, or unable to be contacted by telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infection That Requires Removal of the Neurosurgical Device | Six months post-operation | 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. |
Countries
United States
Participant flow
Recruitment details
214 subjects signed consent. 198 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 100 |
| Total | 198 |
Baseline characteristics
| Characteristic | Saline | Total | Vancomycin |
|---|---|---|---|
| Age, Continuous | 64 Years | 63.5 Years | 63 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 100 participants | 198 participants | 98 participants |
| Sex: Female, Male Female | 37 Participants | 77 Participants | 40 Participants |
| Sex: Female, Male Male | 63 Participants | 121 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 100 |
| other Total, other adverse events | 2 / 98 | 5 / 100 |
| serious Total, serious adverse events | 0 / 98 | 0 / 100 |
Outcome results
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.
Time frame: Six months post-operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vancomycin | Incidence of Infection That Requires Removal of the Neurosurgical Device | 97 Participants |
| Saline | Incidence of Infection That Requires Removal of the Neurosurgical Device | 98 Participants |