RECRUITING

NPWTi on Closure of Chronic Pressure Sores

Conditions

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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

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.

Official Title

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

Quick Facts

Study Start:2022-09-26

Study Completion:2024-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05598398

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 Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Robert Galiano, MD

CONTACT

3129267037

robert.galiano@nm.org

Kristin Huffman, B.S.

CONTACT

3129267037

kristin.huffman@northwestern.edu

Principal Investigator

Robert Galiano, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

Robert Galiano, MD, PRINCIPAL_INVESTIGATOR, Northwestern 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 Date2022-09-26

Study Completion Date2024-08

Study Record Updates

Study Start Date2022-09-26

Study Completion Date2024-08

Terms related to this study

Additional Relevant MeSH Terms

Pressure Sore