A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects (NP-PWD2)

This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Injuries; Skin Wound
• Intervention / Treatment: Device: NP-PWD; Device: Wound Vac

Detailed Description

A study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and asked to consent to participate in the study. Following consent subjects will be randomized to receive treatment of one of the two study arms. Arm 1, the standard of care arm, will receive KCI Wound VAC Granulofoam. Arm 2, the study arm, will receive treatment with NP-PWD. Prior to the initial application, wound evaluations and photography will be completed to include assessment of infection with wound swabs. The wound dressing will be assessed for the need for change every 2-3 days and changed if clinically indicated (following each device IFU). Subjects will be followed for up to nine days post initial application. At minimum, the randomized treatment will be applied for 2 days after initial application for a subject to be considered completed. Subject who do not complete the treatment course (minimum of 2 days of treatment), may be replaced per investigators discretion. Follow up data will be gathered at each change/removal of the NP-PWD or Wound VAC. The data collected will include indications for dressing change, dressing change process, photographs and assessments for wound healing, infection, and adverse events. Gathered clinical data of the enrolled subjects will be used to evaluate the feasibility in using the NP-PWD device for wound healing management.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Northeast Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

All subjects enrolled must meet ALL the following criteria:

1. Patients 18 years of age or older of either gender
2. Have an open skin or soft tissue defect requiring treatment

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

1. Active malignant disease at the study site
2. Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
3. On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study
4. Pregnant at enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NP-PWD application; Patients randomized to NP-PWD arm will have the NP-PWD device applied to their wound.	Device: NP-PWD; Application of NP-PWD device.
Active Comparator: Standard of Care Wound VAC application; Patients randomized to the standard of care arm will have the standard wound vac device applied to their wound.	Device: Wound Vac; Application of wound vac device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and usability of device in treatment.	The number and type of issues with the device will be documented to determine feasibility and usability. Events such as complications with application, device changes and early removal and rationale for events during the period the patient has the study device applied and throughout the entire enrollment period.	Seven to nine days post application.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound readiness for closure	The treating physician will use their best medical judgment to assess the wound bed using rate of epithelization, signs of infection, exposed tendon or bone and overall appearance of the wound bed to determine the wounds readiness for closure. It will be documented the number of subjects from both groups that after treatment are ready to be grafted, or are no longer requiring surgery.	Seven to nine days post application.
Incidence of colony forming units.	Colony forming units are assessed by obtaining wound swabs and analysis of presence of colony forming units.	Seven to nine days post application.
Ease of use of device by healthcare providers	At each research visit the staff will be asked if they had any questions, concerns, complaints or comments about the device or dressing. There is not a separate healthcare provider questionnaire, but any information obtained will be placed in the comments section of the source documents and the feedback will be provided to manufacture.	Seven to nine days post application.
Tolerability of the device by patient subjects	Tolerability of device by subjects will be assessed by observation of the length of time subjects were able to keep the dressing on. The subject will be asked if they have any concern or complaints about the device or dressing. Their response and if applicable the reason for removal will all be documented.	Seven to nine days post application.

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Investigators: Principal Investigator: Rodney Chan, MD, The Metis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Negative pressure therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Soft Tissue Injuries
• Other Study ID Numbers: NP-PWD 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes