A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Feasibility and usability of device in treatment.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All subjects enrolled must meet ALL the following criteria:
- •Patients 18 years of age or older of either gender
- •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:
- •Active malignant disease at the study site
- •Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
- •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
- •Pregnant at enrollment
Outcomes
Primary Outcomes
Feasibility and usability of device in treatment.
Time Frame: Seven to nine days post application.
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.
Secondary Outcomes
- Ease of use of device by healthcare providers(Seven to nine days post application.)
- Tolerability of the device by patient subjects(Seven to nine days post application.)
- Wound readiness for closure(Seven to nine days post application.)
- Incidence of colony forming units.(Seven to nine days post application.)