Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

Complication of Surgical Procedure Clinical Trial

Official title:

Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02006511
• Other study ID #: HP-00057511
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: December 1, 2014

Study information

• Verified date: December 2017
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2014
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Surgical Wound

Intervention

Device:
• Incisional Neg Pressure Wound Therapy (Prevena™)
Negative pressure wound therapy dressing applied over closed surgical incision

Other:
• Standard of Care wound therapy
Gauze type dressing.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deep wound infection		within 30 postoperative days
Secondary	Superficial Wound Infection	Cellulitis or other superficial infection of the wound or tissue immediately surrounding the wound	within 30 postoperative days
Secondary	Wound dehiscence	Spontaneous opening of a previously closed surgical wound	within 30 postoperative days