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Negative Pressure Wound Therapy

Negative Pressure Wound Therapy for Surgical Site Infection

Phase 1 & 2
Waitlist Available
Led By Adam Power, MD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

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.

Eligible Conditions
  • Surgical Site Infection
  • Peripheral Vascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical Site Infection
Secondary outcome measures
Amputation
Emergency room visits
Length of stay
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Negative Pressure Wound TherapyExperimental Treatment1 Intervention
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.
Group II: Current StandardActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor
248 Previous Clinical Trials
53,296 Total Patients Enrolled
Kinetic Concepts, Inc.Industry Sponsor
17 Previous Clinical Trials
1,958 Total Patients Enrolled
Adam Power, MDPrincipal InvestigatorLondon Health Sciences Center
1 Previous Clinical Trials
290 Total Patients Enrolled
~7 spots leftby Sep 2025