Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
|ClinicalTrials.gov Identifier: NCT02084017|
Recruitment Status : Unknown
Verified July 2015 by Dr. Adam Power, Western University, Canada.
Recruitment status was: Recruiting
First Posted : March 11, 2014
Last Update Posted : July 31, 2015
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 or disease||Intervention/treatment||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||April 2016|
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.
- Surgical Site Infection [ Time Frame: 30 days ]Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.
- Length of stay [ Time Frame: Date of discharge ]Duration (in days) the patient stays in hospital post-operatively
- Emergency room visits [ Time Frame: 30 days ]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 ]
- Re-operation rate [ Time Frame: 30 days ]Need for re-operation following graft failure secondary to infection
- Amputation [ Time Frame: 30 days ]Need for amputation post-operatively secondary to infection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084017
|Contact: Adam Power, MD||519-667-6775||Adam.Power@lhsc.on.ca|
|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|
|Principal Investigator:||Adam Power, MD||London Health Sciences Center|