Status:
COMPLETED
Negative Pressure Wound Therapy to Reduce Surgical Site Infection
Lead Sponsor:
Duke University
Collaborating Sponsors:
Kinetic Concepts, Inc.
Conditions:
Patients Undergoing Hepatopancreatobiliary Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at th...
Eligibility Criteria
Inclusion
- Female and male patients 18 years of age or older
- Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
Exclusion
- The need for emergency surgery.
- The need for use of only laparoscopic surgery.
- Presence of bowel obstruction, strangulation, peritonitis or perforation.
- The presence of local or systemic infection preoperatively.
- ASA class ≥4.
- Inability to provide informed consent and authorization.
- Known allergy or hypersensitivity to silver.
- Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.
Key Trial Info
Start Date :
December 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT01905397
Start Date
December 18 2013
End Date
May 26 2021
Last Update
December 2 2022
Active Locations (2)
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1
Indiana University
Indianapolis, Indiana, United States, 46223
2
Duke University Medical Center
Durham, North Carolina, United States, 27710