Intrawound Vancomycin Prophylaxis for Neural Stimulator

Surgical Site Infection Clinical Trial

— IV-DIRT  

Official title:

Intrawound Vancomycin Prophylaxis During Stimulator Re-Implantation: A Multi-Center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221023
• Other study ID #: H16-01496
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 15, 2017
• Est. completion date: December 15, 2021

Study information

• Verified date: October 2020
• Source: University of British Columbia
• Contact: Christopher R Honey, MD, DPhil
• Phone: 6048755894
• Email: chris.honey[@]telus.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.

Description:

Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death.

The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery.

This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked.

The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• individuals who require INS replacement from Dr. C.R. Honey

• individuals who are between the ages of 18 to 80.

• individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon

• individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively

• individuals who are capable of providing informed consent

Exclusion Criteria:

• individuals who have a history of autoimmune disease

• individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study

• individuals who are on immunosuppression or any medication that would influence infection susceptibility

• individuals who are allergic to Vancomycin or Cefazolin

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Implantable Neural Stimulator
• Surgical Site Infection
• Surgical Wound Infection
• Vancomycin

Intervention

Drug:
• Vancomycin Hydrochloride
Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics
• Saline Solution
Individuals in the control arm will receive intrawound saline solution

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Caroom C, Tullar JM, Benton EG Jr, Jones JR, Chaput CD. Intrawound vancomycin powder reduces surgical site infections in posterior cervical fusion. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1183-7. doi: 10.1097/BRS.0b013e31828fcfb5. — View Citation

Doshi PK. Long-term surgical and hardware-related complications of deep brain stimulation. Stereotact Funct Neurosurg. 2011;89(2):89-95. doi: 10.1159/000323372. Epub 2011 Feb 2. — View Citation

Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258. Review. — View Citation

Martin JR, Adogwa O, Brown CR, Kuchibhatla M, Bagley CA, Lad SP, Gottfried ON. Experience with intrawound vancomycin powder for posterior cervical fusion surgery. J Neurosurg Spine. 2015 Jan;22(1):26-33. doi: 10.3171/2014.9.SPINE13826. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device explantation 6 months post surgery	The primary outcome measure will be determined at the 6 month post surgery point, where the binary yes/no question, "was the INS device explanted", will be answered.	6 months