Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT01905397

Collaborator

Kinetic Concepts, Inc. (Industry)

170

Enrollment

Locations

Arms

89.2

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing Hepatopancreatobiliary Surgery	Device: Conventional wound therapy Device: Negative pressure wound therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 18, 2013

Actual Primary Completion Date :

May 26, 2021

Actual Study Completion Date :

May 26, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Surgical Site Infection [30 days post-surgery]

Secondary Outcome Measures

Characterization of surgical site infection [30 days post-surgery]
Characterize the incidence of SSI as superficial incisional, deep incisional, and organ/space as defined by The American College of Surgeons NSQIP (National Surgical Quality Improvement Program) guidelines.
Length of hospital stay [30 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46223
2	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University
Kinetic Concepts, Inc.

Investigators

Principal Investigator: Trey Blazer, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT01905397

Other Study ID Numbers:

Pro00045975

First Posted:

Jul 23, 2013

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Additional relevant MeSH terms:

Surgical Wound Infection

Study Results

No Results Posted as of Jun 8, 2021