Back to results

NPWTi on Closure of Chronic Pressure Sores

Primary Purpose

Pressure Sore

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

V.A.C.Ulta™ Negative Pressure Wound Therapy System

Standard of Care (Wet-to-dry dressings)

About this trial

This is an interventional treatment trial for Pressure Sore

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ischial and sacral wounds at stage 3 and 4.
Any pressure sore that has the potential for a good seal.

Exclusion Criteria:

Any pressure sore that does not have potential for a good seal.
Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
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.

Sites / Locations

Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control (Wet-to-dry dressings)

Treatment (NPWT with Instillation)

Arm Description

Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.

Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cost Analysis

Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.

Number of debridements

Record the total number of debridements performed at the wound site throughout the duration of the study

Successful closure of pressure sores

Patients will be assessed for proper closure of the wound

Full Information

NCT ID

NCT05598398

First Posted

October 20, 2022

Last Updated

November 8, 2022

Sponsor

Northwestern University

Collaborators

1. Study Identification

Unique Protocol Identification Number

NCT05598398

Brief Title

NPWTi on Closure of Chronic Pressure Sores

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Sore

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control (Wet-to-dry dressings)

Arm Type

Active Comparator

Arm Description

Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.

Arm Title

Treatment (NPWT with Instillation)

Arm Type

Experimental

Arm Description

Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore.

Intervention Type

Device

Intervention Name(s)

V.A.C.Ulta™ Negative Pressure Wound Therapy System

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard of Care (Wet-to-dry dressings)

Intervention Description

Wet-to-dry dressings

Primary Outcome Measure Information:

Title

Total Length of Stay

Description

Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

Cost Analysis

Description

Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.

Time Frame

Through study completion, approximately 5 months

Title

Number of debridements

Description

Record the total number of debridements performed at the wound site throughout the duration of the study

Time Frame

Through study completion, approximately 5 months

Title

Successful closure of pressure sores

Description

Patients will be assessed for proper closure of the wound

Time Frame

2 weeks and 6 weeks post-closure surgery

Other Pre-specified Outcome Measures:

Title

Proteomic analysis

Description

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.

Time Frame

1 year post-closure surgery

Title

Bioburden assessment

Description

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.

Time Frame

Through study completion, approximately 5 months

Title

Wound characteristic assessments

Description

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.

Time Frame

1 year post-closure surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ischial and sacral wounds at stage 3 and 4. Any pressure sore that has the potential for a good seal. Exclusion Criteria: Any pressure sore that does not have potential for a good seal. Patients with fecal incontinence (due to potential for pressure sore to be near the anus). Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.). 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Galiano, MD

Phone

3129267037

robert.galiano@nm.org

First Name & Middle Initial & Last Name or Official Title & Degree

Kristin Huffman, B.S.

Phone

3129267037

kristin.huffman@northwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Galiano, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Galiano, MD

Phone

312-926-7037

robert.galiano@nm.org

First Name & Middle Initial & Last Name & Degree

Kristin Huffman

Phone

3129267037

kristin.huffman@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Robert Galiano, MD

12. IPD Sharing Statement

Learn more about this trial

NPWTi on Closure of Chronic Pressure Sores

We'll reach out to this number within 24 hrs