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

March 5, 2014
September 4, 2014
July 2014
April 2015   (final data collection date for primary outcome measure)
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.
Surgical Site Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Surgical site infection is defined by the CDC Guideslines for surgical site infection and by the Szilagyi classification of vascular wound infections.
Complete list of historical versions of study NCT02084017 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Surgical Wound Infection
  • Peripheral Vascular Diseases
  • 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
  • Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
  • 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.
    Intervention: 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.
    Intervention: Device: Prevena (Negative Pressure Wound Therapy Device)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
April 2016
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Adam Power, MD 519-667-6775 Adam.Power@lhsc.on.ca
Canada
 
NCT02084017
RRG-104871
No
Dr. Adam Power, Western University, Canada
Western University, Canada
Kinetic Concepts, Inc.
Principal Investigator: Adam Power, MD London Health Sciences Center
Western University, Canada
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP