NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing
Condition: Partial-thickness Burn; Ulcer
MeSH terms: Ulcer
Study type: Interventional

Summary: 
      This study is designed to assess the efficacy and economics of two NPWT (negative pressure
      wound therapy) branded devices of wound healing outcomes. It is also designed to assess the
      effectiveness of negative pressure and negative pressure with continuous irrigation on
      multiple parameters of wound healing. It is a single-center, open-label, active controlled,
      parallel-group trial that aims to determine the efficacy of Quantum with simultaneous
      irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will
      be randomized to receive either PRO negative press therapy with simultaneous irrigation; or
      PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy.
      Outcomes will include rates of wound healing, time to closure, number of surgeries, length of
      stay, and days to heal.
    

Detailed description: 
      Subjects will be taken to the operating room for the initial debridement procedure of the
      wound. At the end of the procedure, subjects who continue to meet all inclusion and no
      exclusion criteria will be randomized in a 1:1:1 ratio to be treated with either PRO, PRO
      with simultaneous irrigation (PROI), or KCI Ulta NPWT. Prior to study initiation sealed
      prenumbered randomization envelopes will be provided to the research staff and used to obtain
      randomization assignment. Opening of the randomization envelope will occur intraoperatively
      at the conclusion of the initial surgical debridement of the wound and conformation of all
      eligibility requirements. Study staff will use the randomization number labels contained in
      the envelop. The number will become the subject ID. The assignment will be subjects
      randomized to PRO, PRO with simultaneous irrigation, or KCI Ulta NPWT.

      The research staff will note treatment assignments on the intra operative randomization CRF
      and instruct the investigator. Treatment therapy wound dressings will be applied in the
      operating room or in the patient's room immediately after surgery per the investigators
      discretion, according to the manufacturer's recommendations. In order to ensure consistent
      study treatment, subjects will receive assigned treatment therapies within their study arm
      after the initial and any subsequent surgical debridements until the wound is deemed ready
      for closure or coverage by the Investigator. Subjects randomized to the PRO with simultaneous
      irrigation Treatment arm are the only subjects that will receive irrigation therapy at any
      time during the study treatment period. If irrigation therapy is discontinued, subjects in
      the Treatment arm will transition to PRO NPWT without irrigation. Subjects randomized to the
      PRO Control arm will receive NPWT only from the PRO therapy unit.
    

Intervention name(s): NPWT PRO without irrigation; NPWT PRO with irrigation; KCI Ulta
Intervention type(s): Device; Device; Device
Intervention description(s): NPWT PRO without irrigation.; NPWT PRO with irrigation (saline); KCI Ulta NPWT without irrigation
Other intervention name(s): Cardinal Quantum NPWT PRO; Cardinal Quantum NPWT PRO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic ulcer; pressure ulcer; chronic or traumatic wound; sub-acute or dehisced wound