Back to results

Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Primary Purpose

Patients Undergoing Hepatopancreatobiliary Surgery

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Conventional wound therapy

Negative pressure wound therapy

About this trial

This is an interventional prevention trial for Patients Undergoing Hepatopancreatobiliary Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Indiana University
Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Conventional wound therapy

Arm Description

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

Traditional wound therapy (sterile bandages and dressing)

Outcomes

Primary Outcome Measures

Participants With a Surgical Site Infection

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01905397

First Posted

July 18, 2013

Last Updated

November 30, 2022

Sponsor

Duke University

Collaborators

Kinetic Concepts, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01905397

Brief Title

Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

December 18, 2013 (Actual)

Primary Completion Date

May 26, 2021 (Actual)

Study Completion Date

May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Kinetic Concepts, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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 the first clinic visit after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients Undergoing Hepatopancreatobiliary Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Negative Pressure Wound Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Conventional wound therapy

Arm Type

Active Comparator

Arm Description

Traditional wound therapy (sterile bandages and dressing)

Intervention Type

Device

Intervention Name(s)

Conventional wound therapy

Intervention Description

Sterile bandages and wound coverings

Intervention Type

Device

Intervention Name(s)

Negative pressure wound therapy

Other Intervention Name(s)

Prevena Incision Management System; ActiVAC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Participants With a Surgical Site Infection

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of Surgical Site Infections by Type

Description

Time Frame

30 days post-surgery

Title

Length of Hospital Stay

Description

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

Time Frame

Up to 62 days post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Blazer, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46223

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Negative Pressure Wound Therapy to Reduce Surgical Site Infection

We'll reach out to this number within 24 hrs