Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

Not Applicable

Withdrawn

• Conditions: Complication of Surgical Procedure
• Interventions: Other: Standard of Care wound therapy; Device: Incisional Neg Pressure Wound Therapy (Prevena™)

• Registration Number: NCT02006511
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-13
• Study Start: 2013-12-01
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-10
• Primary Completion: 2014-12-01
• Study Completion: 2014-12-01
• Status Verified: 2017-12
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care wound dressing	Standard of Care wound therapy	Standard of care wound dressing of gauze and tape or the equivalent applied to the surgical site
Incisional Neg Pressure Wound Therapy	Incisional Neg Pressure Wound Therapy (Prevena™)	Incisional negative pressure wound therapy dressings applied to the surgical site

Primary Outcome Measures

Name	Time	Method
Deep wound infection	within 30 postoperative days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States