NCT06552481

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The Metis Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Skin Wound
• Soft Tissue Injuries

Interventions

Type	Name	Description
DEVICE	NP-PWD	Application of NP-PWD device.
DEVICE	Wound Vac	Application of wound vac device.

Timeline

• Start date: 2023-08-16
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study