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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
Male or female adults 18 years or older
Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post procedure
Awards & highlights

PREVENA-AMP Trial 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.Check my eligibility
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.See study design
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.

PREVENA-AMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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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.

PREVENA-AMP Trial 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

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

PREVENA-AMP 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
443 Previous Clinical Trials
145,060 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
Seroma Research Study Groups: Prevena, Standard Care
Seroma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are engaged in the implementation of this trial?

"Currently, 4 sites are welcoming participants into this trial. These include Philadelphia and Abington as well as Valhalla with additional locations available. It is encouraged to select the closest site in order to minimize any travel burden associated with participation."

Answered by AI

How many participants has the clinical trial been able to recruit?

"Affirmative. According to the clinicaltrials.gov database, this research endeavour is presently in search of participants and is targeting 440 people from 4 distinct medical centres. It was first published on January 15th 2019 with its most recent update occurring November 3rd 2021."

Answered by AI

Is there still an opportunity to join this experiment?

"Affirmative. As per the information published on clinicaltrials.gov, this research endeavour is actively looking for enrollees. It was initially posted online on January 15th 2019 and revised most recently in November 2021. The project aims to recruit a total of 440 individuals from 4 distinct medical centres."

Answered by AI
~20 spots leftby Jul 2024