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

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ClinicalTrials.gov Identifier: NCT03935659
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
loay kabbani, MD, Henry Ford Health System

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 Intervention/treatment Phase
Surgical Site Infection Groin Infections Device: Negative Pressure Pressure Wound Therapy Procedure: Standard Wound Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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)
Masking Description: As this intervention necessitated the use of an external negative wound therapy device, masking is not possible
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 26, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




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



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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 Index<0.35, rest pain, tissue loss and/or non-healing ulcers
  • Procedure time >240 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935659


Contacts
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Contact: Loay Kabbani, MD 313-844-0246 LKABBAN1@hfhs.org
Contact: Ali Rteil, MD 2024272899 arteil1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Loay Kabbani, MD    313-844-0246    LKABBAN1@hfhs.org   
Contact: Ali Rteil, MD    2024272899    arteil1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Loay Kabbani, MD Henry Ford Health System

Additional Information:
Publications:

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Responsible Party: loay kabbani, MD, Principle Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03935659     History of Changes
Other Study ID Numbers: 11956
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by loay kabbani, MD, Henry Ford Health System:
Negative Pressure Wound Therapy
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes