Utilizing RENASYS◊ DYNAFLOW Instillation Therapy System for Wound Management in Adults With Acute and Chronic Wounds

• Patients must provide their own written informed consent
• Patient is at least 18 years old at time of consent
• Patient is or will be admitted as an in-patient, able to attend all required study visits and willing to undergo NPWTi treatment
• Patient must be able to follow instructions and in the opinion of the Investigator deemed capable of completing protocol requirements

• Patient has a target wound that meets all the following:

  • Is acute (e.g. traumatic, partial thickness burns), sub-acute (e.g. surgical dehisced), or chronic (e.g. pressure or diabetic ulcer)
  • Is an open wound with surface area 45-350 cm² and includes at least one planar dimension (length or width) ≥10 cm
  • In the opinion of the Investigator, would be suitable for/could benefit from NPWTi treatment

Exclusion Criteria:

• Patient with target wound contraindicated to use of the product under investigation, ancillary products or their components per the RENASYS◊ DYNAFLOW Instillation Therapy System IFU

• Patient with target wound(s):

  • Highly exuding
  • Located in anatomical areas where maintaining a seal is problematic with tunnels or undermining that would prevent NPWT application
  • Severe, unmanageable peri-wound compromise
  • Uncontrolled clinically unstable localized infection
  • Contains non-sutured hemostatic agents (e.g., bone wax, absorbable gelatin sponge, spray wound sealant) that may be disrupted by NPWTi
  • Requires drain device
  • Containing surgical flaps or skin grafts
  • Uncontrolled bleeding where hemostasis has not been achieved

• Patient with a medical or physical condition that, in the opinion of the Investigator, would preclude participation in the study, including but not limited to:

  • Systemic infection or sepsis
  • Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that will interfere with wound healing (e.g., biologics).
  • Concomitant therapy local to the target wound that would interfere or conflict with NPWTi (e.g., compression, continuous enzymatic debriders)
  • Require hyperbaric or high-pressure environment
• Patient with a known allergy or hypersensitivity to the product under investigation, ancillary products or their components
• Patient has participated in this trial previously and/or were withdrawn
• Patient is participating in the treatment period of another interventional clinical trial within thirty (30) days of informed consent, or during the study
• Patient has skin features (e.g., tattoos, skin color, pre-existing scarring) which in the opinion of the Investigator could impact the study assessment or risk identification of the patient in study documentation/wound photography
• Patient meets the definition of vulnerable persons per ISO14155 section 3.56[1]
• Patient with a known history of poor compliance with medical treatment that in the opinion of the Investigator would preclude full participation in the trial

• Patient is of childbearing potential (WOCBP) [2] who at the time of screening/treatment meets any of the following:

  • Pregnant as determined by a positive pregnancy test (serum or urine)
  • Breastfeeding or lactating

  • Planning to become pregnant during study participation

    • [1] ISO 14155:2026 Section 3.56 states: Vulnerable subject - individuals who are unable to fully understand all aspects of the clinical investigation that are relevant to the decision to participate, or who can be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response determined by physical, social, economic and environmental factors or processes.
    • [2] Women of Childbearing Potential (WOCBP) are defined as individuals with a uterus who have reached menarche and are not post-menopausal (defined as ≥12 consecutive months of amenorrhea without an alternative medical cause) and who have not undergone permanent surgical sterilisation (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).