CompletedNot Applicable

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

United States, Italy272 participantsStarted 2019-01-15

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Overall Rate of Wound Complications

Timeframe: 30 days post procedure

Trial details

NCT IDNCT03773575

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-15

Results submitted2026-01-26

View on ClinicalTrials.gov More Amputation trials