Negative Pressure Therapy for Groin Wounds
Status: | Recruiting |
---|---|
Conditions: | Hospital, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | December 2016 |
End Date: | December 2019 |
Contact: | Thomas Bernik, MD |
Email: | thomas.bernik@ehmchealth.org |
Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
The purpose of this study is to compare wound infection rates between negative pressure
therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular
surgery involving groin incisions.
therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular
surgery involving groin incisions.
This is a prospective, investigator-initiated, post-market data collection study comparing
wound infection rates among patients undergoing vascular surgery involving groin incisions.
Patients will be randomized on the day of surgery to receive the traditional sterile dry
dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as
per the standard protocol with the first dressing change at postoperative day 2 or 3, or at
the discretion of the attending surgeon. The patients with Prevena dressing will have the
dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the
first outpatient visit. The Primary Objective of this study is to see if using negative
pressure therapy decreases the rate of infection. The Secondary Objectives will include
multivariate analysis to understand which patients may have a compounded benefit from Prevena
(e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage
and will be used in this study for on-label purposes.
wound infection rates among patients undergoing vascular surgery involving groin incisions.
Patients will be randomized on the day of surgery to receive the traditional sterile dry
dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as
per the standard protocol with the first dressing change at postoperative day 2 or 3, or at
the discretion of the attending surgeon. The patients with Prevena dressing will have the
dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the
first outpatient visit. The Primary Objective of this study is to see if using negative
pressure therapy decreases the rate of infection. The Secondary Objectives will include
multivariate analysis to understand which patients may have a compounded benefit from Prevena
(e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage
and will be used in this study for on-label purposes.
Inclusion Criteria:
- Patients undergoing vascular surgery with a groin incision.
Exclusion Criteria:
- Allergy to silver.
We found this trial at
1
site
350 Engle St
Englewood, New Jersey 07631
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: Thomas Bernik, MD
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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