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Negative Pressure Wound Therapy for Abdominal (colorectal, liver, or pancreas) Surgery - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether negative pressure wound therapy (NPWT) helps to lower the rate of surgical site infections (SSI) in patients having abdominal surgery compared to routine post-operative wound care.

What is the Condition Being Studied?

Wound care for abdominal (colorectal, liver, or pancreas) surgery

Who Can Participate in the Study?

Adult men and women who:
- Are scheduled for an elective open colorectal or hepatopancreatobiliary (liver or pancreas) surgery.

You may not join the study if you are having emergency or laparoscopic surgery

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like a flip of a coin) to one of two groups.

--- Group One will get a standard wound dressing over their surgical incision.
--- Group Two will have a negative pressure wound therapy (either Prevena Incision Management System or ActiVAC) that will be put on their surgical incision.

- We will monitor you for post-operative infection the day of your surgery, 4-5 days after surgery and again between 15 and 45 days after your surgery.

You will not need to have any additional clinic visits outside of your standard postoperative care.

Your records will also be monitored for any side effects of your dressing or device.

Study Details

Full Title
A Randomized Phase II Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
Principal Investigator
General Surgeon
Protocol Number
IRB:PRO00045975
NCT:NCT01905397
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698