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

NCT03463434 | Completed

• 1 other identifier: CR-SS2017-007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pressure Ulcer

Keywords

pressure ulcer treatment; wound healing

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer healing

  Volume (mm3)

  up to 12 weeks

Secondary Outcomes (2)

• New Pressure Ulcers

  up to 12 weeks

• Length of stay

  up to a year

Study Arms (2)

Air Fluidized Therapy

EXPERIMENTAL

Patients will be placed on the Envella AFT bed

Device: Air Fluidized Therapy

Continuous Low Pressure-LAL

ACTIVE COMPARATOR

Patients will receive a Continuous low pressure mattress with low air loss

Device: Continuous Low Pressure-LAL

Interventions

Air Fluidized Therapy DEVICE

AFT bed used for pressure injury treatment

Air Fluidized Therapy

Continuous Low Pressure-LAL DEVICE

Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment

Continuous Low Pressure-LAL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient has an unstable spinal cord injury
• Patient weighs less than 70 lbs or more than 350 lbs.
• The primary study PI site has had previous flaps or grafts with significant associated scarring which is clinically thought to impede wound contracture.
• Patients with PIs where bone exposure is \> 2 cm2 in area.
• 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
• The primary study PI is located over the trochanteric head of the femur.
• Patients that are currently taking or have taken in the last 6 weeks chemotherapy which is known to be cyto-toxic, or anti-angiogenic
• Patients currently require immune modulating drugs (Humira (alalimumab), Orencia (abatacept), etc.)

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (2)

Noland Health Anniston

Anniston, Alabama, 36207, United States

Location

Noland Health

Birmingham, Alabama, 35242, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 13, 2018
• Study Start: May 10, 2018
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: August 15, 2019

Record last verified: 2018-09

Locations

US (2)