Negative Pressure Wound Therapy for the Prevention of Surgical Site

Status Recruiting

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.

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT02084017
Study type	Interventional
Source	Western University, Canada
Contact	Adam Power, MD
Phone	519-667-6775
Email	Adam.Power@lhsc.on.ca
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 2014
Completion date	April 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Completed	`NCT00536796` - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets	N/A
Completed	`NCT00371371` - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)	Phase 1/Phase 2
Recruiting	`NCT00173602` - The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients	N/A
Completed	`NCT00163267` - Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel	Phase 2/Phase 3
Completed	`NCT00228384` - GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study	Phase 4
Completed	`NCT00106327` - Improving Functioning in Peripheral Arterial Disease	N/A
Completed	`NCT00049907` - Cardiac and Renal Disease Study (CARDS)	N/A
Completed	`NCT00000614` - Prevention of Recurrent Venous Thromboembolism (PREVENT)	Phase 3
Completed	`NCT00005392` - Epidemiology of Venous Disease	N/A
Recruiting	`NCT05596760` - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers	N/A
Recruiting	`NCT00539266` - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia	Phase 2/Phase 3
Completed	`NCT00520312` - Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease	N/A
Completed	`NCT00541307` - GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)	N/A
Terminated	`NCT00504088` - Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia	Phase 4
Completed	`NCT00533104` - Cell Therapy in Chronic Limb Ischemia	Phase 1/Phase 2
Enrolling by invitation	`NCT05459818` - Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
Completed	`NCT03875846` - Intraoperative Simultaneous Pressure Guided Revascularization Study
Active, not recruiting	`NCT05110677` - Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
Active, not recruiting	`NCT02856230` - An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms