Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery

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 the first clinic visit after surgery.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Hepatopancreatobiliary Surgery
• Intervention / Treatment: Device: Negative pressure wound therapy; Device: Conventional wound therapy

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46223
      • Indiana University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Negative Pressure Wound Therapy; The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure	Device: Negative pressure wound therapy; The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.; Other Names: Prevena Incision Management System; ActiVAC
Active Comparator: Conventional wound therapy; Traditional wound therapy (sterile bandages and dressing)	Device: Conventional wound therapy; Sterile bandages and wound coverings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With a Surgical Site Infection	Number and percentage of participants with at least 1 surgical site infection (SSI).	30 days after surgery; assessed at 4-5 days and 30 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Surgical Site Infections by Type	Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP [National Surgical Quality Improvement Program] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections.	30 days post-surgery
Length of Hospital Stay	Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.	Up to 62 days post-surgery

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Kinetic Concepts, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2013
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: Pro00045975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes