Completed

NCT Number: NCT01905397

Negative Pressure Wound Therapy to Reduce Surgical Site Infection

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.

Completed

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Key information

Conditions

Patients Undergoing Hepatopancreatobiliary Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional wound therapy

Device

Sterile bandages and wound coverings

Negative pressure wound therapy

Device

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

Primary outcomes

Participants With a Surgical Site Infection

Time frame: 30 days after surgery; assessed at 4-5 days and 30 days post-operation

Number and percentage of participants with at least 1 surgical site infection (SSI).

Secondary outcomes

Number of Surgical Site Infections by Type

Time frame: 30 days post-surgery

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.
Length of Hospital Stay

Time frame: Up to 62 days post-surgery

Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Kinetic Concepts, Inc.

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2021
Study completion: 2021
First posted: Jul 23, 2013
Registry last updated: Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.