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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Valhalla

Westchester Medical Center, Valhalla, New York, United States, 10595

Philadelphia

Thomas Jefferson University/Hospital, Philadelphia, Pennsylvania, United States, 19107

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female adults 18 years or older
  • 2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
  • 3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
  • 4. Informed Consent signed by patient
  • 1. Minors under 18 years
  • 2. Women who are pregnant or breastfeeding
  • 3. Patients undergoing emergent or guillotine amputation
  • 4. Patients having BOTH legs amputated
  • 5. Patients with sensitivity to silver
  • 6. Unwilling or unable to provide informed consent
  • 7. Inability to comply with planned study procedures

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Thomas Jefferson University,

Paul DiMuzio, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

2024-08-15