Clinical trial NCT02006511: Incisional Negative Pressure Dressing on Clean Closed Groin Incisions
Official title: Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complication of Surgical Procedure
Keywords: incisional negative pressure wound therapy
groin incision
incisional VAC
Prevena
groin wound
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Deep wound infection
timeFrame: within 30 postoperative days
Secondary outcomes:
measure: Superficial Wound Infection
timeFrame: within 30 postoperative days
measure: Wound dehiscence
timeFrame: within 30 postoperative days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery
name: Rachel Bluebond-Langer, MD
role: PRINCIPAL_INVESTIGATOR
References: