RECRUITING

NPWTi on Closure of Chronic Pressure Sores

Description

The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.

Conditions

Pressure Sore
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Related Conditions:

Pressure Sore

Study Overview

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Study Details

Study overview

The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.

Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial

NPWTi on Closure of Chronic Pressure Sores

Condition
Pressure Sore
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

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. Ischial and sacral wounds at stage 3 and 4.
  • 2. Any pressure sore that has the potential for a good seal.
  • 1. Any pressure sore that does not have potential for a good seal.
  • 2. Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
  • 3. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
  • 4. Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Robert Galiano, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2024-08