Trial Outcomes & Findings for Topical Vancomycin for Neurosurgery Wound Prophylaxis (NCT NCT02284126)
NCT ID: NCT02284126
Last Updated: 2025-10-29
Results Overview
Classified as superficial incisional, deep incisional, or organ/space (intradural) infection
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1103 participants
Primary outcome timeframe
30 days & 90 days (+/- 7 days) postoperatively
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Topical Vancomycin
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
Control group, receive standard of care only
|
|---|---|---|
|
Overall Study
STARTED
|
552
|
551
|
|
Overall Study
COMPLETED
|
484
|
489
|
|
Overall Study
NOT COMPLETED
|
68
|
62
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Vancomycin for Neurosurgery Wound Prophylaxis
Baseline characteristics by cohort
| Measure |
Topical Vancomycin
n=484 Participants
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
n=489 Participants
Control group, receive standard of care only
|
Total
n=973 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
556 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
208 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
403 Participants
n=5 Participants
|
403 Participants
n=7 Participants
|
806 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
337 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
676 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days & 90 days (+/- 7 days) postoperativelyClassified as superficial incisional, deep incisional, or organ/space (intradural) infection
Outcome measures
| Measure |
Topical Vancomycin
n=484 Participants
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
n=489 Participants
Control group, receive standard of care only
|
|---|---|---|
|
Any Surgical-site Infection as Evidenced by Surgeon or Attending Physician Diagnosis, or Signs and Symptoms of Infection Assessed by Phone Call Interview or at In-office Follow-up Consultation
Subject visited doctor and received antibiotics
|
18 participants
|
19 participants
|
|
Any Surgical-site Infection as Evidenced by Surgeon or Attending Physician Diagnosis, or Signs and Symptoms of Infection Assessed by Phone Call Interview or at In-office Follow-up Consultation
Subject reports any possible symptom of surgical site infection
|
344 participants
|
355 participants
|
|
Any Surgical-site Infection as Evidenced by Surgeon or Attending Physician Diagnosis, or Signs and Symptoms of Infection Assessed by Phone Call Interview or at In-office Follow-up Consultation
Positive skin culture or hospital readmission for surgical site infection
|
5 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 30 days & 90 days (+/- 7 days) postoperativelyPopulation: Out of 1103 enrolled subjects, only 973 subjects completed the study and their data have been analyzed and presented here.
As evidenced by surgeon or attending physician diagnosis, or signs and symptoms of infection assessed by phone call interview or at in-office follow-up consultation. Classified as superficial incisional, deep incisional, or organ/space (intradural) infection.
Outcome measures
| Measure |
Topical Vancomycin
n=484 Participants
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
n=489 Participants
Control group, receive standard of care only
|
|---|---|---|
|
Number of Subjects That Reported Any Surgical-site Infections
|
344 participants
|
355 participants
|
SECONDARY outcome
Timeframe: 6-20 hours post-operativelyPopulation: 440 participants who were administered vancomycin provided serum samples for analysis. The remaining participants were discharged on the same day as their operation and thus were not available to provide serum samples. Serum samples were not collected from participants who received standard of care.
Vancomycin levels in serum will be tested after surgery, any additional fluid collections, but if and only if clinically indicated. A serum vancomycin level of \>3.0 mg/dl is considered positive.
Outcome measures
| Measure |
Topical Vancomycin
n=440 Participants
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
Control group, receive standard of care only
|
|---|---|---|
|
Number of Participants With Positive Serum Vancomycin Levels
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: 90 days postoperativelyPopulation: Swabs were collected only from participants who received Vancomycin.
Microbial swabs will be obtained by the clinical coordinator preoperatively, post-operatively, at 10-14 days and at 90 days. Staph aureus isolates from mannitol growth will be tested for vancomycin resistance.
Outcome measures
| Measure |
Topical Vancomycin
n=484 Participants
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
Control group, receive standard of care only
|
|---|---|---|
|
Number of Participants Who Developed a Previously Undetected Vancomycin Resistance
|
0 Participants
|
—
|
Adverse Events
Topical Vancomycin
Serious events: 49 serious events
Other events: 121 other events
Deaths: 5 deaths
Standard of Care
Serious events: 65 serious events
Other events: 119 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Topical Vancomycin
n=552 participants at risk
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
n=551 participants at risk
Control group, receive standard of care only
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing loss
|
0.72%
4/552 • Number of events 4 • 90 days
|
1.3%
7/551 • Number of events 7 • 90 days
|
|
General disorders
Death
|
0.91%
5/552 • Number of events 5 • 90 days
|
1.1%
6/551 • Number of events 6 • 90 days
|
|
Immune system disorders
Allergy Symptoms
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal Changes
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Infections and infestations
Surgical Site Infection
|
0.72%
4/552 • Number of events 4 • 90 days
|
0.73%
4/551 • Number of events 4 • 90 days
|
|
General disorders
Unplanned Medical Visit
|
3.8%
21/552 • Number of events 22 • 90 days
|
6.7%
37/551 • Number of events 37 • 90 days
|
|
Infections and infestations
Urinary Tract Infeciton
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.54%
3/551 • Number of events 3 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.54%
3/552 • Number of events 3 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Nervous system disorders
Vision Impairment
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.36%
2/551 • Number of events 2 • 90 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Endocrine disorders
Pancreatic Necrosis
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Vascular disorders
Hematoma
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
General disorders
Bleeding at drain site
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Cardiac disorders
Left Ventricular Thrombus
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Nervous system disorders
Facial Sensory Loss
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Nervous system disorders
Meningitis
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Nervous system disorders
Dysarthria/Dysphagia
|
0.00%
0/552 • 90 days
|
0.54%
3/551 • Number of events 3 • 90 days
|
|
Nervous system disorders
Hemiparesis
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.54%
3/551 • Number of events 3 • 90 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Nervous system disorders
Cognitive Impairment
|
0.36%
2/552 • Number of events 2 • 90 days
|
0.36%
2/551 • Number of events 2 • 90 days
|
|
Nervous system disorders
Stroke/Cerebrovasular accident
|
0.54%
3/552 • Number of events 3 • 90 days
|
0.36%
2/551 • Number of events 2 • 90 days
|
|
General disorders
Gait instability
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Nervous system disorders
Drop foot
|
0.00%
0/552 • 90 days
|
0.18%
1/551 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Hallucination
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Infections and infestations
Sepsis
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
General disorders
Chest Pain
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Vascular disorders
Pulmonary Embolism
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Nervous system disorders
Seizure
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Nervous system disorders
Pneumocephalus
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Cardiac disorders
Pericarditis
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
General disorders
Pain
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
General disorders
Epidural Abscess
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
|
Infections and infestations
Discharge
|
0.18%
1/552 • Number of events 1 • 90 days
|
0.00%
0/551 • 90 days
|
Other adverse events
| Measure |
Topical Vancomycin
n=552 participants at risk
Treatment group, receive 2 g topical vancomycin hydrochloride (1 g applied as powder, 1 g mixed with sterile solution and applied as paste) at the time of closure, in addition to the standard of care for wound prophylaxis
Vancomycin: Topically applied powder and paste to surgical site at time of closure.
|
Standard of Care
n=551 participants at risk
Control group, receive standard of care only
|
|---|---|---|
|
Immune system disorders
Allergy Symptoms
|
5.8%
32/552 • Number of events 32 • 90 days
|
6.0%
33/551 • Number of events 33 • 90 days
|
|
Metabolism and nutrition disorders
Gastrointestinal changes
|
5.4%
30/552 • Number of events 33 • 90 days
|
6.2%
34/551 • Number of events 36 • 90 days
|
|
Ear and labyrinth disorders
Hearing Change
|
4.3%
24/552 • Number of events 26 • 90 days
|
4.7%
26/551 • Number of events 27 • 90 days
|
|
General disorders
Unplanned Medical Visit
|
6.3%
35/552 • Number of events 38 • 90 days
|
4.7%
26/551 • Number of events 30 • 90 days
|
Additional Information
Dr. E. Sander Connolly Jr.
Columbia University Irving Medical Center
Phone: 2123054118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place