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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure

Clinicaltrials.gov identifier NCT03935659

Recruitment Status Withdrawn (not recruiting patients.)

First Posted May 2, 2019

Last update posted February 10, 2021

Study Description

Brief summary:

The purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (NPWT) vs standard sterile gauze therapy on the incidence of surgical site infections (SSI) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.

  • Condition or Disease:Surgical Site Infection
    Groin Infections
  • Intervention/Treatment: Device: Negative Pressure Pressure Wound Therapy
    Procedure: Standard Wound Care
  • Phase: N/A
Detailed Description

Eligible patients are randomized pre-operatively into either a standard dressing or NPWT for the groin incision. - 1 The control group receive a standard sterile gauge dressing over the groin incision. The dressing is removed on post-operative day #2 and the wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge. - 2 The intervention group will receive a NPWT dressing which will be applied in the operating room under sterile conditions. The NPWT dressing will be removed on Post operative day 5. The wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.

Study Design
  • Study Type: Interventional
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Vascular Surgery Patients Undergoing Common Femoral Artery Exposure
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: October 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Negative Pressure wound therapy
The intervention group will receive a negative pressure dressing which will be applied in the operating room under sterile conditions. The brand of negative pressure dressing will be based on surgeon preference or center availability. The NPWT dressing will be removed on day 5 postoperatively or at discharge, whichever occurs first, and the groin wound inspected for any evidence of infection or dehiscence, and daily thereafter until discharge.
Device: Negative Pressure Pressure Wound Therapy
Investigators will be using a Negative Pressure Wound Therapy Powered Suction Pump on primarily closed groin wounds after open common femoral artery exposure, The Negative pressure dressing will be applied in a sterile fashion in the operating room. The negative pressure dressing will be removed at day 5 postoperatively, or at discharge, whichever occurs first.
Active Comparator: Standard gauze therapy
The control group will receive a standard sterile gauge dressing over the groin incision. The dressing will be removed on post-operative day #2 and the wound will be inspected for any complications, followed by daily dressing changes and wound inspections until discharge.
Procedure: Standard Wound Care
Standard sterile gauze coverage of the primarily closed groin wound.
Outcome Measures
  • Primary Outcome Measures: 1. Superficial surgical site infection [ Time Frame: 30 days postoperatively ]
    Surgical site infection as defined by the Center for disease control and prevention criteria
  • Secondary Outcome Measures: 1. Mortality [ Time Frame: 30 days ]
    Occurrence of mortality within 30 days of surgery
  • 2. Limb Loss [ Time Frame: 30 days and 1 year ]
    Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery
  • 3. Emergency department visit for wound complication [ Time Frame: within 30 days of surgery ]
    Number of participants returning to the emergency department for wound complications within 30 days of surgery
  • 4. Local reaction to negative wound dressing [ Time Frame: 5 days postoperatively ]
    Occurrence of a local reaction at the site of the negative pressure apparatus during application
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria: One or more of the following

- Body Mass Index >30 kg/m2

- Critical limb ischemia defined by Ankle Brachial Index240 min

- End Stage Renal Disease on dialysis

- Glycated hemoglobin ≥ 8.5%

- Transfusion ≥ 3 units packed Red Blood Cells

- Previous femoral artery cut-down

Exclusion Criteria:Any of the following

- Preexisting groin infection

- Complete vacuum seal cannot be achieved with negative pressure device

- Allergy to Adhesive Material

- Groin Surgery within last 30 days

Contacts and Locations
Contacts
Locations

United States, Michigan
Henry Ford Hospital
Detroit

Sponsors and Collaborators

Henry Ford Health System

Investigators

Principal Investigator: Loay Kabbani, MD Henry Ford Health System

More Information