Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients

Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists.

The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.

Study Overview

• Status: Withdrawn
• Conditions: Complication of Surgical Procedure
• Intervention / Treatment: Device: Incisional Neg Pressure Wound Therapy (Prevena™); Other: Standard of Care wound therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female 18 years of age or greater
• Scheduled elective vascular surgery which requires groin incision. Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
• Meets high risk criteria according to the following rating system

• Scores at least 8 points for the following risk factors:

  • MAJOR 4 points:

• BMI of <18 kg/m2 or ≥BMI 40 kg/m2 ***
• Insulin dependent Diabetes Mellitus*

• Dialysis (hemodialysis or peritoneal dialysis)**

  • INTERMEDIATE 2 points:

• Previous groin surgery
• Diabetes Mellitus not requiring insulin*
• Chronic lung disease GOLD >2
• On long-term immunosuppressive medication (>3 months at time of enrollment)
• Chronic kidney disease (defined as a GFR <30ml/min/1.73m2 for 3 months)**
• Previous lower extremity or abdominal wall radiotherapy radiotherapy

• BMI between 35 and 40***

  • MINOR 1 point:

• Previous abdominal surgery
• Peripheral vascular disease
• Female gender
• Age >75 years old

• Hospitalized at least 7 days before surgery

  *, **, *** mutually exclusive, highest score should be used

• Capable of providing informed consent or has a legally authorized representative (LAR) if unable to provide informed consent
• Willing and able to adhere to the study visit schedule

Exclusion Criteria:

• Subjects meeting any of the following criteria may not be enrolled in the study:
• Is pregnant
• Has a systemic infection at the time of surgery (ie bacteremia)
• Has a remote body site infection at the time of surgery (ie UTI)
• Has a known allergy or hypersensitivity to silver, adhesive, or dressing material
• Has a requirement for competing therapy (ie open negative pressure wound therapy)
• Is simultaneously participating in another interventional trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Incisional Neg Pressure Wound Therapy; Incisional negative pressure wound therapy dressings applied to the surgical site	Device: Incisional Neg Pressure Wound Therapy (Prevena™); Negative pressure wound therapy dressing applied over closed surgical incision
Active Comparator: Standard of care wound dressing; Standard of care wound dressing of gauze and tape or the equivalent applied to the surgical site	Other: Standard of Care wound therapy; Gauze type dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Deep wound infection	within 30 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial Wound Infection	Cellulitis or other superficial infection of the wound or tissue immediately surrounding the wound	within 30 postoperative days
Wound dehiscence	Spontaneous opening of a previously closed surgical wound	within 30 postoperative days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Rachel Bluebond-Langer, MD, University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Prevena; incisional negative pressure wound therapy; groin incision; incisional VAC; groin wound
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: HP-00057511