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Trial Outcomes & Findings for Quality Control: A Prospective Analysis of EVD Effectiveness (NCT NCT02484287)

NCT ID: NCT02484287

Last Updated: 2023-07-03

Results Overview

Infection rates of EVD patients

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

24 months

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure
Ventriclear EVD Antibiotic Catheter
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Integra External Drainage Catheter
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Codman Bactiseal EVD Catheter Set
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Overall Study
STARTED
15
26
19
Overall Study
COMPLETED
0
0
0
Overall Study
NOT COMPLETED
15
26
19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quality Control: A Prospective Analysis of EVD Effectiveness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ventriclear EVD Antibiotic Catheter
n=15 Participants
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Integra External Drainage Catheter
n=26 Participants
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Codman Bactiseal EVD Catheter Set
n=19 Participants
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Total
n=60 Participants
Total of all reporting groups
Age, Categorical
<=18 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
17 Participants
n=7 Participants
12 Participants
n=5 Participants
38 Participants
n=4 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
9 Participants
n=7 Participants
7 Participants
n=5 Participants
21 Participants
n=4 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
13 Participants
n=7 Participants
8 Participants
n=5 Participants
31 Participants
n=4 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
13 Participants
n=7 Participants
11 Participants
n=5 Participants
29 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
8 Participants
n=4 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
21 Participants
n=7 Participants
12 Participants
n=5 Participants
43 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
Region of Enrollment
United States
15 participants
n=5 Participants
26 participants
n=7 Participants
19 participants
n=5 Participants
60 participants
n=4 Participants

PRIMARY outcome

Timeframe: 24 months

Infection rates of EVD patients

Outcome measures

Outcome measures
Measure
Ventriclear EVD Antibiotic Catheter
n=15 Participants
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Integra External Drainage Catheter
n=26 Participants
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Codman Bactiseal EVD Catheter Set
n=19 Participants
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Infection Rates of EVD Patients
0 Participants
0 Participants
0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Months

duration of EVD placement in days

Outcome measures

Outcome measures
Measure
Ventriclear EVD Antibiotic Catheter
n=26 Participants
The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Integra External Drainage Catheter
n=15 Participants
The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Codman Bactiseal EVD Catheter Set
n=19 Participants
The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Duration of EVD Placement
11 days
Standard Deviation 7
13 days
Standard Deviation 10
10 days
Standard Deviation 5

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: This data was not collected and is no longer available.

Comparable cost of each device

Outcome measures

Outcome data not reported

Adverse Events

Integra External Drainage Catheter

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ventriclear EVD Antibiotic Catheter

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Codman Bactiseal EVD Catheter Set

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Blair Apple

University of Oklahoma Health Science Center

Phone: 4052714658

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place