Trial Outcomes & Findings for Multicenter Infection Surveillance Study Following Open Heart Surgery (NCT NCT00673712)

NCT ID: NCT00673712

Last Updated: 2018-01-19

Results Overview

Pneumonia diagnosed during hospitalization

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 647 participants
• Primary outcome timeframe: 30 days postoperative
• Results posted on: 2018-01-19

Participant Flow

Participant milestones

Measure	Continuous Sternal Block Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid Based Analgesia Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Overall Study STARTED	321	326
Overall Study COMPLETED	321	326
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Infection Surveillance Study Following Open Heart Surgery

Baseline characteristics by cohort

Measure	Continuous Sternal Block n=321 Participants Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid Based Analgesia n=326 Participants Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN	Total n=647 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 12.1 • n=5 Participants	65.2 years STANDARD_DEVIATION 11.5 • n=7 Participants	64.7 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	97 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	220 Participants n=5 Participants	229 Participants n=7 Participants	449 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 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
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) White	273 Participants n=5 Participants	277 Participants n=7 Participants	550 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	321 participants n=5 Participants	326 participants n=7 Participants	647 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days postoperative

Population: all randomized subjects

Pneumonia diagnosed during hospitalization

Outcome measures

Measure	Continuous Sternal Block n=321 Participants Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid Based Analgesia n=326 Participants Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Hospital Acquired Pneumonia	8 participants	18 participants

SECONDARY outcome

Timeframe: 30 days postoperative

Population: all randomized subjects

surgical site infection diagnosed within 30 days post surgery

Outcome measures

Measure	Continuous Sternal Block n=321 Participants Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid Based Analgesia n=326 Participants Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Surgical Site Infection	17 participants	19 participants

SECONDARY outcome

Timeframe: primary admission

Population: all randomized subjects

time (days) from date of admission to discharge

Outcome measures

Measure	Continuous Sternal Block n=321 Participants Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic	Opioid Based Analgesia n=326 Participants Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics Opioid based analgesia: Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Hospital Length of Stay	8.8 days Standard Deviation 29.9	9.5 days Standard Deviation 29.6

Adverse Events

Continuous Sternal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Opioid Based Analgesia

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

Sr. Director Clinical Research

Halyard Health

Phone: 5132538033

Email: alan.dine@hyh.com

Results disclosure agreements

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