Surgical Wound Infection
Conditions
Keywords
colorectal surgery
Brief summary
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.
Detailed description
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.
Interventions
DEVICEON-Q Silver soaker System
Continuous infusion of local anesthetic to surgical site
DRUGPatient controlled analgesia
IV opioids delivered via PCA
Sponsors
Halyard Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women, \>18 years of age; * Scheduled for elective colon procedure; * Ability to complete patient survey questionnaires; * Provision of informed consent
Exclusion criteria
* Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine); * Procedures for hemorrhoids; * Inability to perform follow up assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical site infection | 30 days postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Hospital length of stay | Average 1 week |
Outcome results
None listed