Trial Outcomes & Findings for Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH) (NCT NCT00548132)

Results Overview

The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1088 participants

Primary outcome timeframe

2 years

Results posted on

2013-09-12

Participant Flow

The patients were recruited from two ICUs at BJH. The nurse was asked to page the research coordinators on patients who were scheduled to have a central venous catheter placed for IV access.

Patients or family member authorized to consent for the patient (if the patient was not competent to consent to the study) were approached by study personnel for inclusion into the study. Written informed consent was obtained for all subjects and randomization group was assigned in blocks of 4.

Participant milestones

Participant milestones
Measure	Standard of Care Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.	Chlorhexidine-impregnated Foam Dressing
Overall Study STARTED	534	554
Overall Study Consented to Study	534	554
Overall Study COMPLETED	534	554
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=534 Participants Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.	Chlorhexidine-impregnated Foam Dressing n=554 Participants Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.	Total n=1088 Participants Total of all reporting groups
Age Continuous	58.26 years STANDARD_DEVIATION 16.88 • n=5 Participants	58.70 years STANDARD_DEVIATION 16.83 • n=7 Participants	58.47 years STANDARD_DEVIATION 16.84 • n=5 Participants
Sex: Female, Male Female	304 Participants n=5 Participants	325 Participants n=7 Participants	629 Participants n=5 Participants
Sex: Female, Male Male	230 Participants n=5 Participants	229 Participants n=7 Participants	459 Participants n=5 Participants
Region of Enrollment United States	534 participants n=5 Participants	554 participants n=7 Participants	1088 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.

The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization

Outcome measures

Outcome measures
Measure	Standard of Care n=534 Participants Standard of care	Chlorhexidine Impregnated Sponge n=554 Participants Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms	4.74 BSIs /1000 catheter days	4.72 BSIs /1000 catheter days

SECONDARY outcome

Timeframe: 2 years

This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.

Outcome measures

Outcome measures
Measure	Standard of Care n=534 Participants Standard of care	Chlorhexidine Impregnated Sponge n=554 Participants Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
Clinical Sepsis Episodes/Per 1000 Catheter Days	7.8 sepsis episodes/1000 catheter days	8.5 sepsis episodes/1000 catheter days

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine-impregnated Foam Dressing

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

Bernard C. Camins, MD

Washington University School of Medicine

Phone: 3144548351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place