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

Completed · Not applicable

Conditions studied: Pressure Ulcer

In brief

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.

Key facts

Study ID

NCT03463434

Run by

Hill-Rom

People needed

5

Starts

2018-05-10

Expected to finish

2019-08-14

Last updated by the study team

2019-08-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.)

Where it is running

• Noland Health Anniston — Anniston, Alabama, United States
• Noland Health — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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