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

Peripheral Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02084017
• Other study ID #: RRG-104871
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 5, 2014
• Last updated: July 30, 2015
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Western University, Canada
• Contact: Adam Power, MD
• Phone: 519-667-6775
• Email: Adam.Power[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Surgical Wound Infection
• Vascular Diseases
• Wound Infection

Intervention

Device:
• Prevena (Negative Pressure Wound Therapy Device)
No other details required.
• Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Kinetic Concepts, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection	Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.	30 days	No
Secondary	Length of stay	Duration (in days) the patient stays in hospital post-operatively	Date of discharge	No
Secondary	Emergency room visits	Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment	30 days	No
Secondary	All-cause mortality		30 days	No
Secondary	Re-operation rate	Need for re-operation following graft failure secondary to infection	30 days	No
Secondary	Amputation	Need for amputation post-operatively secondary to infection	30 days	No