AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries

A Randomized Controlled Pilot Study Comparing Air Fluidized Therapy (AFT) to a Continuous Low Pressure (CLP) Low Air Loss (LAL) Support Surface in the Treatment of Stage 3 or 4 Pressure Injuries

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Air Fluidized Therapy; Device: Continuous Low Pressure-LAL

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Noland Health Anniston
    • Birmingham, Alabama, United States, 35242
      • Noland Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient's treatment goals are curative or maintaining, and not palliative in nature.
2. Patient is compliant with standard clinical care for their admitted condition.
3. Patient's age is between 18 and 85 years
4. Patient is expected to have at least a 3-4-week length of stay (from date of assessment) in the treating LTACH
5. Patient must have at least one stage 3 or 4 PI located on the weight bearing aspect of the patient's truncal /pelvic region
6. Patients or their legal authorized representative must be willing and able to provide written informed consent.

Exclusion Criteria:

1. Patient has an unstable spinal cord injury
2. Patient weighs less than 70 lbs or more than 350 lbs.
3. The primary study PI site has had previous flaps or grafts with significant associated scarring which is clinically thought to impede wound contracture.
4. Patients with PIs where bone exposure is > 2 cm2 in area.
5. Patients with active osteomyelitis (via clinical assessment) or patients who have been diagnosed with osteomyelitis and have not yet completed a 6-8-week course of antibiotics
6. The primary study PI is located over the trochanteric head of the femur.
7. Patients that are currently taking or have taken in the last 6 weeks chemotherapy which is known to be cyto-toxic, or anti-angiogenic
8. Patients currently require immune modulating drugs (Humira (alalimumab), Orencia (abatacept), etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air Fluidized Therapy; Patients will be placed on the Envella AFT bed	Device: Air Fluidized Therapy; AFT bed used for pressure injury treatment
Active Comparator: Continuous Low Pressure-LAL; Patients will receive a Continuous low pressure mattress with low air loss	Device: Continuous Low Pressure-LAL; Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure ulcer healing	Volume (mm3)	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Pressure Ulcers	new pressure ulcers	up to 12 weeks
Length of stay	Length of stay in the Long-term Acute Care Hospital	up to a year

Collaborators and Investigators

• Sponsor: Hill-Rom

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): August 14, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: wound healing; pressure ulcer treatment
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Skin Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: CR-SS2017-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No