Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

Completed · Not applicable

Conditions studied: Amputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma, Wound Infection, Surgical, Lymph Leakage

In brief

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 incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.

Key facts

Study ID

NCT03773575

Run by

Thomas Jefferson University

People needed

272

Starts

2019-01-15

Expected to finish

2024-08-15

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Minors under 18 years
• Women who are pregnant or breastfeeding
• Patients having BOTH legs amputated
• Patients with sensitivity to silver
• Unwilling or unable to provide informed consent
• Inability to comply with planned study procedures

Where it is running

• Westchester Medical Center — Valhalla, New York, United States
• Thomas Jefferson University/Hospital — Philadelphia, Pennsylvania, United States
• Gemelli Hospital — Roma, RM, Italy

Full record on ClinicalTrials.gov

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