Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

NCT ID: NCT02006511

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-01
• Study Completion Date: 2014-12-01

Brief Summary

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.

Conditions

Complication of Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Incisional Neg Pressure Wound Therapy

Incisional negative pressure wound therapy dressings applied to the surgical site

Group Type: EXPERIMENTAL

Incisional Neg Pressure Wound Therapy (Prevena™)

Intervention Type: DEVICE

Negative pressure wound therapy dressing applied over closed surgical incision

Standard of care wound dressing

Standard of care wound dressing of gauze and tape or the equivalent applied to the surgical site

Group Type: ACTIVE_COMPARATOR

Standard of Care wound therapy

Intervention Type: OTHER

Gauze type dressing.

Interventions

Incisional Neg Pressure Wound Therapy (Prevena™)

Negative pressure wound therapy dressing applied over closed surgical incision

Intervention Type: DEVICE

Standard of Care wound therapy

Gauze type dressing.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Bluebond-Langer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00057511

Identifier Type: -

Identifier Source: org_study_id