Pressure Ulcers
Conditions
Keywords
Pressure Ulcer treatment Mattresses, Home Care, Extended Care, Wound measurements
Brief summary
To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.
Detailed description
Subjects will be recruited from those presenting to the wound clinic and meet the inclusion criteria. A total of 30 evaluable subjects will be recruited for this study from up to 2 wound care clinics /home health agencies (15 in Home Care and 15 in Extended Care). Subjects will be followed by weekly wound assessments for a period of 12 weeks or until their wounds heal. The outcome measurement is the rate of healing over the 12 week period.
Interventions
DEVICEP400 mattress
The P400 mattress will be placed for a period of 12 weeks.
Sponsors
Hill-Rom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has multiple Stage II pressure ulcers or at least one Stage III or IV pressure ulcer(s) (as per National Pressure Ulcer Advisory Panel Staging guidelines) located either on the trunk or pelvis (which would include trochanter and ischial ulcers ) having a clean wound bed of less than or equal to 25% necrotic tissue at the base of the pressure ulcer. 2. Subjects may have heel ulcers, however these ulcers may not be considered a target study ulcer. 3. Subject, or legally authorized representative is able to provide informed consent 4. Subject weighs between 70 and 350 pounds 5. Subject's nutritional status is thought to be adequate to support wound healing 6. Subject qualifies for a Group 2 support surface (Target study ulcer must be at least 8 cm\^2 in area to qualify)
Exclusion criteria
1. Subject's target ulcer is unstageable due to eschar or necrosis or a suspected Deep Tissue Injury may be located at the base of the wound. 2. Subject has unresolved systemic infection, or pressure ulcer infection, or a history of osteomyelitis, or greater than 25% eschar or necrotic tissue present in the wound bed. 3. Patient has already been enrolled in this study 4. Patient has a recent history of non-compliance with pressure ulcer offloading, repositioning, or other areas of the treatment care plan, which would jeopardize wound healing if continued. 5. Care plan goals are palliative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ulcer Surface Area at Week 12 | 12 Weeks | The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of New Ulcers | 12 Weeks | incidence of new ulcers while on the study surface |
| Healing Rate Per Week | 12 weeks | The mean change in area per week for all ulcers |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| P400 All patients will receive the P400 mattress
P400 mattress: The P400 mattress will be placed for a period of 12 weeks. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | P400 |
|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 21.5 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change From Baseline in Ulcer Surface Area at Week 12
The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.
Time frame: 12 Weeks
Population: Ulcers decreased an average of 7.96 cm\^2 (+/- 8.1 cm\^2) over the 12 week period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P400 Support Surface | Change From Baseline in Ulcer Surface Area at Week 12 | -7.96 cm^2 | Standard Deviation 8.1 |
Secondary
Healing Rate Per Week
The mean change in area per week for all ulcers
Time frame: 12 weeks
Population: Rate of change in area (healing) for all ulcers on all subjects in area (cm\^2)/week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| P400 Support Surface | Healing Rate Per Week | -0.92 cm^2/week | Standard Deviation 0.79 |
Secondary
Incidence of New Ulcers
incidence of new ulcers while on the study surface
Time frame: 12 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| P400 Support Surface | Incidence of New Ulcers | 0 percentage of participants |