AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer; Crush Injuries
Study type: Interventional

Summary: 
      Patients who have at least one stage 3 or 4 PI and are admitted to a participating treating
      facility will be candidates for study enrollment. Patients must provide written informed
      consent. Standard care for their admitted condition will be provided for the patients except
      for support surface selection, laboratory blood tests, PI measurement(s) by the 3-D camera
      measurement tool, and added pain and patient satisfaction assessments. Clinical assessments
      will be recorded weekly as described below. Patients will be followed until discharge from
      the LTACH or until 1) they require a different mattress for their admitted condition; or 2)
      reach a maximum of 12 weeks in the LTACH. At study discontinuation, a clinical general
      assessment of the quality of improvement of the PIs will be recorded.
    

Detailed description: 
      Patients admitted to the LTACH with at least one stage 3 or 4 PI will be evaluated for
      possible inclusion/exclusion criteria. Patients will be approached by the investigator, or
      their designee to acquire patient informed consent. If provided, patients will be randomized
      to their designated support surface, the bed will be ordered and patients will begin the
      study with a baseline study visit (week 0) that will include:

        -  Date and time of study bed placement

        -  A brief medical history, that includes current diagnoses, assessment of co-morbidities,
           an assessment of neurologic status, nutritional status, level of mobility, history of
           current PI's, documentation of treatments that have been applied to PI(s) prior to study
           entry

        -  Braden PU risk assessment (overall and subscores)

        -  Assessment of pain associated with the PI using a pain numeric rating scale (NRS), where
           patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible
           pain") [21]

        -  Blood for CBC, Albumin, Pre-Albumin, CRP will be collected.

        -  PI assessments: all PI's located on the lower truncal region of the patient's body will
           be assessed both subjectively by the treating clinicians for clinical signs of
           infection, as well as by a 3D wound assessment tool.

        -  Overall health status assessment

      Subsequent weekly study visits will continue for a maximum of 12 weeks. The interim study
      visit documentation will include:

        -  Overall health status assessment of health (whether the patient's health is improving,
           maintaining, or worsening)

        -  Skin assessment to document any new PI's that may have developed,

        -  Braden PU risk assessment (overall and subscores)

        -  3D Wound assessments of all lower truncal PI's,

        -  Clinical Assessment of signs and symptoms of wound infection

        -  Confirmation of support surface type,

        -  Documentation of adverse device effects, device-related complaints (within 24 hours of
           effect/complaint).

      Clinical Resource Utilization Data: documentation of the following data will aim to achieve
      estimated clinical resources associated with caring for PIs:

        -  Documentation of dressing supplies,

        -  Debridement method, duration and frequency

        -  Type of antibiotics dosage, frequency, and duration

        -  Other pharmacologic agents used for wounds with dosage, frequency, and duration

        -  Assessment of pain

        -  Rental bed cost estimates

        -  Documentation of professional healthcare visits and/or types of healthcare services in
           the preceding week.

        -  Documentation of acute care hospitalizations

        -  An estimate of LTACH staff time devoted to wound care per day for that study week.

      At study discharge, which may occur at the time of study PI healing, LTACH discharge, or upon
      stepdown from the randomized study surface) or for other reasons, a final study visit will be
      completed that includes:

        -  Date and time of study bed removal

        -  Overall health status assessment,

        -  Skin assessment to document any new PI's that may have developed,

        -  Braden PU risk assessment (includes subscores),

        -  3D wound assessments of all truncal PI's,

        -  Clinical assessment of signs and symptoms of wound infection

        -  Confirmation of bed support surface type

        -  Documentation of adverse device effects, device related complaints (within 24 hours of
           effect/complaint).

        -  Clinical Resource Utilization Data:

             -  documentation of dressing supplies,

             -  debridement method, duration and frequency

             -  type of antibiotics, dosage, frequency, and duration

             -  other pharmacologic agents used for wounds with dosage, frequency, and duration,

             -  rental bed cost estimates

             -  documentation of professional healthcare visits and/or types of healthcare services
                in the preceding week.

             -  documentation of acute care hospitalizations

             -  an estimate of LTACH staff time devoted to wound care per day for that study week.

        -  Assessment of pain

        -  A patient bed satisfaction assessment will be completed if the patient is able to
           communicate

        -  Blood for CBC, Albumin, Pre-Albumin, CRP will be collected
    

Intervention name(s): Air Fluidized Therapy; Continuous Low Pressure-LAL
Intervention type(s): Device; Device
Intervention description(s): AFT bed used for pressure injury treatment; Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This multi-center, randomized, open-label, two treatment, parallel group study is designed to obtain comparative data on the healing rates of type 3 & 4 pressure injuries.
The randomization schedule will be set up in blocks, and within a block, the randomization numbers will be assigned equally to the two treatment groups (Envella AFT, FIS bed surface types). A separate randomization schedule will be set up for each stage (3, 4 PI). The anticipated number of investigative sites is 3.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pressure ulcer treatment; wound healing