Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Duke University

Status: Completed

Conditions: Patients Undergoing Hepatopancreatobiliary Surgery

Treatments: Device: Conventional wound therapy; Device: Negative pressure wound therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01905397

Pro00045975

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Negative Pressure Wound Therapy

Active Comparator group

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

Treatment:

Device: Negative pressure wound therapy

Conventional wound therapy

Active Comparator group

Description:

Traditional wound therapy (sterile bandages and dressing)

Treatment:

Device: Conventional wound therapy