NPWTi on Closure of Chronic Pressure Sores

Pressure Sore Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598398
• Other study ID #: STU00216075
• Status: Recruiting
• Phase: Phase 4
• Start date: September 26, 2022
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Robert Galiano, MD
• Phone: 3129267037
• Email: robert.galiano[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ischial and sacral wounds at stage 3 and 4.

2. Any pressure sore that has the potential for a good seal.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Pressure Sore
• Pressure Ulcer

Intervention

Device:
• V.A.C.Ulta™ Negative Pressure Wound Therapy System
The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) - cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Other:
• Standard of Care (Wet-to-dry dressings)
Wet-to-dry dressings

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proteomic analysis	Amount of bacteria present in frozen tissue that was collected at treatment day 1 will be determined and compared between groups using a two sample t-test.	1 year post-closure surgery
Other	Bioburden assessment	Photos of the wound will be taken with a specialized bioburden camera, which can pick up on bacterial load of the wound. Photos will be taken before debridement, after debridement, after every dressing change, and on the day of surgery.	Through study completion, approximately 5 months
Other	Wound characteristic assessments	Wound characteristics collected by the 3D imaging as well as bioburden collected by the bioburden camera will be compared between the control and study groups. Each respective comparison will involve 2 independent sample t-tests.	1 year post-closure surgery
Primary	Total Length of Stay	Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery	up to 3 months
Secondary	Cost Analysis	Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.	Through study completion, approximately 5 months
Secondary	Number of debridements	Record the total number of debridements performed at the wound site throughout the duration of the study	Through study completion, approximately 5 months
Secondary	Successful closure of pressure sores	Patients will be assessed for proper closure of the wound	2 weeks and 6 weeks post-closure surgery