Pressure UlcerNCT03463434
AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries
A study testing Air Fluidized Therapy and Continuous Low Pressure-LAL in people with Pressure Ulcer, run by Hill-Rom at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Air Fluidized Therapy and Continuous Low Pressure-LAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2018to 14 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Noland Health Anniston
Anniston, Alabama, 36207
Noland Health
Birmingham, Alabama, 35242
About this study
Official title: 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.
Read the 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
- Conditions
- Pressure Ulcer
- Being tested
- Air Fluidized Therapy, Continuous Low Pressure-LAL
- Keywords
- pressure ulcer treatment, wound healing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Fluidized TherapyDevice
AFT bed used for pressure injury treatment
Continuous Low Pressure-LALDevice
Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment
| Study group | Role | What they receive |
|---|---|---|
| Air Fluidized Therapy | Experimental | Patients will be placed on the Envella AFT bed Receives: Device: Air Fluidized Therapy |
| Continuous Low Pressure-LAL | Active comparator | Patients will receive a Continuous low pressure mattress with low air loss Receives: Device: Continuous Low Pressure-LAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer healing
Volume (mm3)
Measured: up to 12 weeks
Secondary outcomes (2)
New Pressure Ulcers
new pressure ulcers
Measured: up to 12 weeks
Length of stay
Length of stay in the Long-term Acute Care Hospital
Measured: up to a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start10 May 2018
- Primary completion14 Aug 2019
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463434
- Sponsor's protocol ID
- CR-SS2017-007
- Status last verified
- Sep 2018
- First submitted
- 26 Feb 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03463434
- Acronym / sponsor ID
- CR-SS2017-007
- Conditions
- Pressure Ulcer
- Keywords
- pressure ulcer treatment, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 10 May 2018 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Air Fluidized Therapy | Experimental | Device: Air Fluidized TherapyPatients will be placed on the Envella AFT bed |
| Continuous Low Pressure-LAL | Active comparator | Device: Continuous Low Pressure-LALPatients will receive a Continuous low pressure mattress with low air loss |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Fluidized TherapyAFT bed used for pressure injury treatment | Device | Air Fluidized Therapy |
| Continuous Low Pressure-LALContinuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment | Device | Continuous Low Pressure-LAL |
Primary outcome
Pressure ulcer healing
Time frame: up to 12 weeks
Volume (mm3)
2 secondary outcomes
New Pressure Ulcers
Time frame: up to 12 weeks
Length of stay
Time frame: up to a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Fluidized Therapy and Continuous Low Pressure-LAL in people with Pressure Ulcer, run by Hill-Rom at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer healing (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.