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Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

Primary Purpose

Complication of Surgical Procedure

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incisional Neg Pressure Wound Therapy (Prevena™)
Standard of Care wound therapy
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complication of Surgical Procedure focused on measuring incisional negative pressure wound therapy, groin incision, incisional VAC, Prevena, groin wound

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Incisional Neg Pressure Wound Therapy

Standard of care wound dressing

Arm Description

Incisional negative pressure wound therapy dressings applied to the surgical site

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

Outcomes

Primary Outcome Measures

Deep wound infection

Secondary Outcome Measures

Superficial Wound Infection
Cellulitis or other superficial infection of the wound or tissue immediately surrounding the wound
Wound dehiscence
Spontaneous opening of a previously closed surgical wound

Full Information

First Posted
November 13, 2013
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT02006511
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never performed and closed.
Study Start Date
December 1, 2013 (Actual)
Primary Completion Date
December 1, 2014 (Actual)
Study Completion Date
December 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Surgical Procedure
Keywords
incisional negative pressure wound therapy, groin incision, incisional VAC, Prevena, groin wound

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incisional Neg Pressure Wound Therapy
Arm Type
Experimental
Arm Description
Incisional negative pressure wound therapy dressings applied to the surgical site
Arm Title
Standard of care wound dressing
Arm Type
Active Comparator
Arm Description
Standard of care wound dressing of gauze and tape or the equivalent applied to the surgical site
Intervention Type
Device
Intervention Name(s)
Incisional Neg Pressure Wound Therapy (Prevena™)
Intervention Description
Negative pressure wound therapy dressing applied over closed surgical incision
Intervention Type
Other
Intervention Name(s)
Standard of Care wound therapy
Intervention Description
Gauze type dressing.
Primary Outcome Measure Information:
Title
Deep wound infection
Time Frame
within 30 postoperative days
Secondary Outcome Measure Information:
Title
Superficial Wound Infection
Description
Cellulitis or other superficial infection of the wound or tissue immediately surrounding the wound
Time Frame
within 30 postoperative days
Title
Wound dehiscence
Description
Spontaneous opening of a previously closed surgical wound
Time Frame
within 30 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Bluebond-Langer, MD
Organizational Affiliation
University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

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