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

The Metis Foundation

Status: Completed

Conditions: Soft Tissue Injuries; Skin Wound

Treatments: Device: Wound Vac; Device: NP-PWD

Study type: Interventional

Funder types: Other

Identifiers

NCT06552481

NP-PWD 02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

NP-PWD application

Experimental group

Description:

Patients randomized to NP-PWD arm will have the NP-PWD device applied to their wound.

Treatment:

Device: NP-PWD

Standard of Care Wound VAC application

Active Comparator group

Description:

Patients randomized to the standard of care arm will have the standard wound vac device applied to their wound.

Treatment:

Device: Wound Vac