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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02084017
Other study ID # RRG-104871
Secondary ID
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


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
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