Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

NCT02006511 | Withdrawn

• 1 other identifier: HP-00057511
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

incisional negative pressure wound therapy; groin incision; incisional VAC; Prevena; groin wound

Outcome Measures

Primary Outcomes (1)

• Deep wound infection

  within 30 postoperative days

Secondary Outcomes (2)

• Superficial Wound Infection

  within 30 postoperative days

• Wound dehiscence

  within 30 postoperative days

Study Arms (2)

Incisional Neg Pressure Wound Therapy

EXPERIMENTAL

Incisional negative pressure wound therapy dressings applied to the surgical site

Device: Incisional Neg Pressure Wound Therapy (Prevena™)

Standard of care wound dressing

ACTIVE COMPARATOR

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

Other: Standard of Care wound therapy

Interventions

Incisional Neg Pressure Wound Therapy (Prevena™) DEVICE

Negative pressure wound therapy dressing applied over closed surgical incision

Incisional Neg Pressure Wound Therapy

Standard of Care wound therapy OTHER

Gauze type dressing.

Standard of care wound dressing

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Rachel Bluebond-Langer, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 6, 2023

Record last verified: 2017-12

Locations

US (1)