Status:
UNKNOWN
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Acelity
Conditions:
Amputation
Amputation; Postoperative, Sequelae
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on inciden...
Detailed Description
This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL \& PLACE™ Dressing Kit) on in...
Eligibility Criteria
Inclusion
- Male or female adults 18 years or older
- Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
- Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
- Informed Consent signed by patient
Exclusion
- Minors under 18 years
- Women who are pregnant or breastfeeding
- Patients undergoing emergent or guillotine amputation
- Patients having BOTH legs amputated
- Patients with sensitivity to silver
- Unwilling or unable to provide informed consent
- Inability to comply with planned study procedures
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2024
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT03773575
Start Date
January 15 2019
End Date
August 15 2024
Last Update
May 3 2023
Active Locations (3)
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1
Westchester Medical Center
Valhalla, New York, United States, 10595
2
Thomas Jefferson University/Hospital
Philadelphia, Pennsylvania, United States, 19107
3
Gemelli Hospital
Roma, RM, Italy, 8, 00168