Skin Wound, Soft Tissue Injuries
Conditions
Keywords
Negative pressure therapy
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.
Interventions
Sponsors
The Metis Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and usability of device in treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Wound readiness for closure | Seven to nine days post application. | 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. |
| Incidence of colony forming units. | Seven to nine days post application. | Colony forming units are assessed by obtaining wound swabs and analysis of presence of colony forming units. |
| Ease of use of device by healthcare providers | Seven to nine days post application. | 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. |
| Tolerability of the device by patient subjects | Seven to nine days post application. | 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. |
Countries
United States
Outcome results
None listed