Trial Outcomes & Findings for Prevention of Neurosurgical Wound Infections (NCT NCT00915967)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

214 participants

Primary outcome timeframe

Six months post-operation

Results posted on

2019-04-30

Participant Flow

214 subjects signed consent. 198 subjects were enrolled.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	98	100
Overall Study COMPLETED	97	98
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vancomycin n=98 Participants 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.	Saline n=100 Participants 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.	Total n=198 Participants Total of all reporting groups
Age, Continuous	63 Years n=98 Participants	64 Years n=100 Participants	63.5 Years n=198 Participants
Sex: Female, Male Female	40 Participants n=98 Participants	37 Participants n=100 Participants	77 Participants n=198 Participants
Sex: Female, Male Male	58 Participants n=98 Participants	63 Participants n=100 Participants	121 Participants n=198 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	98 participants n=98 Participants	100 participants n=100 Participants	198 participants n=198 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vancomycin n=98 Participants 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.	Saline n=100 Participants 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.
Incidence of Infection That Requires Removal of the Neurosurgical Device	97 Participants	98 Participants

Adverse Events

Vancomycin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vancomycin n=98 participants at risk 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.	Saline n=100 participants at risk 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.
Surgical and medical procedures Infection	2.0% 2/98 • Number of events 2 • 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	5.0% 5/100 • Number of events 5 • 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

Additional Information

Director of Clinical Trials

Oregon Health & Science University

Phone: 503-494-4314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place