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Negative Pressure Wound Therapy

Negative Pressure Wound Therapy for Amputation Recovery (PREVENA-AMP Trial)

N/A
Recruiting
Led By Paul DiMuzio, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
Must not have
Minors under 18 years
Women who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a closed incision negative pressure dressing (PREVENA) can reduce wound complications and medical costs in patients undergoing lower extremity amputation.

Who is the study for?
Adults over 18 facing lower extremity amputation, either above or below the knee, can join this trial. They must be able to sign a consent form and follow study procedures. Pregnant or breastfeeding women, minors, those with silver sensitivity, and patients having both legs amputated or emergent amputations are excluded.
What is being tested?
The trial is testing PREVENA dressings on surgical wounds from leg amputations to see if they reduce complications like wound separation and infections. Participants will be randomly assigned to use PREVENA or standard care in an open-label comparison.
What are the potential side effects?
Potential side effects of using PREVENA may include skin irritation at the dressing site, allergic reactions if sensitive to materials used in the dressing (like silver), and possible discomfort due to negative pressure application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having or have had an above-knee amputation.
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I am having or have had a below-knee amputation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am not pregnant or breastfeeding.
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I am having an emergency or complete limb removal surgery.
Select...
I have had both of my legs amputated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall rate of wound complications
Secondary study objectives
30-day Return to Operating Room (ROR)
30-day hospital readmissions
Incidence rates of wound complications
+1 more
Other study objectives
30-day hospital variable costs
30-day hospitalization costs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PrevenaExperimental Treatment1 Intervention
PREVENA™ PEEL \& PLACE™ Dressing Kit
Group II: Standard CareActive Control1 Intervention
sterile gauze dressing supplemented with an Ace wrap

Find a Location

Who is running the clinical trial?

AcelityOTHER
5 Previous Clinical Trials
4,080 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
465 Previous Clinical Trials
176,413 Total Patients Enrolled
Paul DiMuzio, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

PREVENA (Negative Pressure Wound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03773575 — N/A
Amputation Research Study Groups: Prevena, Standard Care
Amputation Clinical Trial 2023: PREVENA Highlights & Side Effects. Trial Name: NCT03773575 — N/A
PREVENA (Negative Pressure Wound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03773575 — N/A
~64 spots leftby Jan 2026
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