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Negative Pressure Wound Therapy to Reduce Surgical Site Infection

NCT01905397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2022-12-02

Study results available
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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.

Conditions

  • Patients Undergoing Hepatopancreatobiliary Surgery

Interventions

DEVICE

Conventional wound therapy

Sterile bandages and wound coverings

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.

Sponsors & Collaborators

Principal Investigators

  • Dan Blazer, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-18
Primary Completion
2021-05-26
Completion
2021-05-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905397 on ClinicalTrials.gov