PREVENA™ PEEL & PLACE™ Dressing Kit for Seroma

Phase-Based Progress Estimates
Abington Hospital, Abington, PASeroma+5 MorePREVENA™ PEEL & PLACE™ Dressing Kit - Device
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Amputation Sequelae
  • Seroma
  • Postoperative Wound Infection
  • Amputation
  • Lymphatic Leakage
  • Wound Separation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 30 days post procedure

30 days post procedure
30-day Return to Operating Room (ROR)
30-day hospital readmissions
Incidence rates of wound complications
Length of stay (LOS)
Overall rate of wound complications
Day 30
30-day hospital variable costs
30-day hospitalization costs

Trial Safety

Trial Design

2 Treatment Groups

Standard Care
1 of 2
1 of 2

Active Control

Experimental Treatment

440 Total Participants · 2 Treatment Groups

Primary Treatment: PREVENA™ PEEL & PLACE™ Dressing Kit · No Placebo Group · N/A

Experimental Group · 1 Intervention: PREVENA™ PEEL & PLACE™ Dressing Kit · Intervention Types: Device
Standard CareNoIntervention Group · 1 Intervention: Standard Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days post procedure

Who is running the clinical trial?

5 Previous Clinical Trials
4,080 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
409 Previous Clinical Trials
135,635 Total Patients Enrolled
Paul DiMuzio, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had an amputation above your knee, including emergency amputations that were necessary to save your life.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. According to the 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." - Anonymous Online Contributor

Unverified Answer

Is there still an opportunity to join this experiment?

"Affirmative. As per the information published on, 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.