Status:
COMPLETED
AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries
Lead Sponsor:
Hill-Rom
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 c...
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 acqu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.)
Key Trial Info
Start Date :
May 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03463434
Start Date
May 10 2018
End Date
August 14 2019
Last Update
August 15 2019
Active Locations (2)
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1
Noland Health Anniston
Anniston, Alabama, United States, 36207
2
Noland Health
Birmingham, Alabama, United States, 35242