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Completed

NCT Number: NCT06552481

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

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.

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Key information

Conditions

Skin Wound Soft Tissue Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Baptist

San Antonio, Texas, 78217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NP-PWD

Device

Application of NP-PWD device.

Wound Vac

Device

Application of wound vac device.

Primary outcomes

  1. 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

  1. Wound readiness for closure

    Time frame: 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.

  2. Incidence of colony forming units.

    Time frame: Seven to nine days post application.

    Colony forming units are assessed by obtaining wound swabs and analysis of presence of colony forming units.

  3. Ease of use of device by healthcare providers

    Time frame: 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.

  4. Tolerability of the device by patient subjects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Metis Foundation

Other

Registry information

Acronym: NP-PWD2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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