Trial Outcomes & Findings for Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds (NCT NCT00771238)

NCT ID: NCT00771238

Last Updated: 2024-09-05

Results Overview

New pressure ulcers were assessed

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: at the end of study period (21 days)
• Results posted on: 2024-09-05

Participant Flow

Participant milestones

Measure	P500 Mattress ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress	Standard Care Arm ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
Overall Study STARTED	31	21
Overall Study COMPLETED	31	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds

Baseline characteristics by cohort

Measure	P500 Mattress n=31 Participants ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress	Standard Care Arm n=21 Participants ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.	Total n=52 Participants Total of all reporting groups
Age, Continuous	62.1 Years STANDARD_DEVIATION 11.4 • n=5 Participants	54.8 Years STANDARD_DEVIATION 19.1 • n=7 Participants	59.1 Years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	9 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: at the end of study period (21 days)

Population: Tertiary Care ICU patients

New pressure ulcers were assessed

Outcome measures

Measure	P500 Mattress n=31 Participants ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress	Standard Care Arm n=21 Participants ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
Indicence of Pressure Ulcers	0 participants	4 participants

SECONDARY outcome

Timeframe: End of study

Population: Tertiary Care ICU patients

Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only

Outcome measures

Measure	P500 Mattress n=31 Participants ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress	Standard Care Arm n=21 Participants ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
Cost of Rental Beds	0 US Dollars	4116 US Dollars

Adverse Events

P500 Mattress

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Care Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	P500 Mattress n=31 participants at risk ICU patients placed on a TC500 bed with standard pressure ulcer prevention care Total Care P500 Mattress: Study mattress	Standard Care Arm n=21 participants at risk ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
Skin and subcutaneous tissue disorders Patient fall out of bed	3.2% 1/31 • Number of events 1	0.00% 0/21

Additional Information

Joyce Black, PhD, RN

Nebraska Medical Center

Phone: 402-559-6573

Email: JBlack@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place