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Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization

NCT02084017 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-07-31

No results posted yet for this study

Summary

The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s).

Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector.

The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.

Conditions

  • Surgical Wound Infection
  • Peripheral Vascular Diseases

Interventions

DEVICE

Prevena (Negative Pressure Wound Therapy Device)

No other details required.

DEVICE

Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing

Sponsors & Collaborators

  • Kinetic Concepts, Inc.

    collaborator INDUSTRY

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Adam Power, MD · London Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-10-31
Completion
2016-04-30

Countries

  • Canada

Study Locations

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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 NCT02084017 on ClinicalTrials.gov