Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-18

Study Completion Date

2021-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Undergoing Hepatopancreatobiliary Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Negative pressure wound therapy

Intervention Type 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.

Conventional wound therapy

Traditional wound therapy (sterile bandages and dressing)

Group Type ACTIVE_COMPARATOR

Conventional wound therapy

Intervention Type DEVICE

Sterile bandages and wound coverings

Interventions

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Conventional wound therapy

Sterile bandages and wound coverings

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Prevena Incision Management System; ActiVAC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No