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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Western University, Canada
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
Dr. Adam Power, Western University, Canada
ClinicalTrials.gov Identifier:
NCT02084017
First received: March 5, 2014
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Surgical Wound Infection
Peripheral Vascular Diseases
Device: Prevena (Negative Pressure Wound Therapy Device)
Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection

Resource links provided by NLM:


Further study details as provided by Western University, Canada:

Primary Outcome Measures:
  • Surgical Site Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.


Secondary Outcome Measures:
  • Length of stay [ Time Frame: Date of discharge ] [ Designated as safety issue: No ]
    Duration (in days) the patient stays in hospital post-operatively

  • Emergency room visits [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment

  • All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Re-operation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Need for re-operation following graft failure secondary to infection

  • Amputation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Need for amputation post-operatively secondary to infection


Estimated Enrollment: 80
Study Start Date: July 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Current Standard
Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing applied under sterile conditions in the operating room following skin closure. Dressing changed post-operative day two and daily thereafter with daily inspection for infection by a physician.
Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
Experimental: Negative Pressure Wound Therapy
A negative pressure therapy (Kinetic Concepts, Inc, San Antionio, Tex) device will be applied under sterile conditions post-operatively and placed on suction (125-150 cm H2O). The device will be removed on post-operative day 4-7 depending on day of discharge.
Device: Prevena (Negative Pressure Wound Therapy Device)
No other details required.
Other Names:
  • Prevena
  • Prevena Incision Management System
  • Negative Pressure Wound Therapy Device
  • Vacuum Therapy

Detailed Description:

The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI > 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device.

Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two.

The data will be analyzed with an intention to treat analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 35
  • Previous femoral exposure
  • Undergoing lower-limb revascularization

Exclusion Criteria:

  • Cannot obtain seal
  • Non-primary wound closure
  • Pre-existing infection
  • Endovascular repair
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084017

Contacts
Contact: Adam Power, MD 519-667-6775 Adam.Power@lhsc.on.ca

Locations
Canada, Ontario
Victoria Hospital Recruiting
London, Ontario, Canada, N6C 2R6
Contact: Adam Power, MD    519-667-6775    Adam.Power@lhsc.on.ca   
Principal Investigator: Adam Power, MD         
Sub-Investigator: Guy DeRose, MD         
Sub-Investigator: Luc Dubois, MD         
Sub-Investigator: Thomas Forbes, MD         
Sponsors and Collaborators
Western University, Canada
Kinetic Concepts, Inc.
Investigators
Principal Investigator: Adam Power, MD London Health Sciences Center
  More Information

No publications provided

Responsible Party: Dr. Adam Power, Principle Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT02084017     History of Changes
Other Study ID Numbers: RRG-104871
Study First Received: March 5, 2014
Last Updated: September 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by Western University, Canada:
Surgical Site Infection
Vascular Surgery
Negative Pressure Wound Therapy

Additional relevant MeSH terms:
Communicable Diseases
Infection
Peripheral Arterial Disease
Peripheral Vascular Diseases
Surgical Wound Infection
Vascular Diseases
Wound Infection
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014