COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-01-15
Study Completion:2024-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03773575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female adults 18 years or older
  2. 2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
  3. 3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
  4. 4. Informed Consent signed by patient
  1. 1. Minors under 18 years
  2. 2. Women who are pregnant or breastfeeding
  3. 3. Patients undergoing emergent or guillotine amputation
  4. 4. Patients having BOTH legs amputated
  5. 5. Patients with sensitivity to silver
  6. 6. Unwilling or unable to provide informed consent
  7. 7. Inability to comply with planned study procedures

Contacts and Locations

Principal Investigator

Paul DiMuzio, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

Westchester Medical Center
Valhalla, New York, 10595
United States
Thomas Jefferson University/Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

  • Paul DiMuzio, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-15
Study Completion Date2024-08-15

Study Record Updates

Study Start Date2019-01-15
Study Completion Date2024-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Amputation
  • Amputation; Postoperative, Sequelae
  • Wound Dehiscence
  • Seroma
  • Wound Infection, Surgical
  • Lymph Leakage