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

In November of 2008, The University of Nebraska Medical Center began a pilot study, and concluded in January of 2010. The primary purpose of this study involved a comparison between the development of pressure ulcers (or the changes within existing pressure ulcers) in participants who used the experimental TC500 Beds as opposed to the standard ICU beds used in the medical center’s Cardiovascular unit. They intended for the TC500 beds, using the P500 mattresses, to replace the standard versions. They also calculated the cost of rental therapy beds for the patients who needed them.

Participating Patients

A total of 52 patients were enrolled in the study. Out of the total number of patients, 31 of them used the TC500 beds, while 21 of them used the standard beds. Every patient involved in the study had pressure ulcers that were up to Stage III. Every participant was subjected to standard pressure ulcer prevention care prior to the experiment. The patients had the following requirements for inclusion:

  • Patients were admitted to the 850 Surgical ICU.
  • Patients had written consent for the study.
  • Patients did not require a specialty bed.
  • Patients were 19 years or older.
  • Patients were within the weight limits of the beds (70-500 lbs.).
Facility and Equipment

The study took place at the medical center’s 850 Cardiovascular Surgical ICU unit. The unit consisted of 12 beds. Six of these beds included the standard care mattresses, while the other six possessed the experimental P500 mattresses. They also prepared additional therapy mattresses in case any of the patients’ conditions worsened to the point where they needed to switch beds. If they needed to rent the additional therapy beds, they recorded the costs.

The Process

The time period for the study was 21 days for each participant. They required test subjects to sign waivers of consent and to give additional consent when they received their normal bed assignments. The participants had their primary and secondary diagnoses on the record, as well as other information such as:

  • Cardiac conditions
  • Pressure ulcer risk assessments
  • Ventilation and oxygenation support measures

During the study, the patients were subject to daily skin assessments. If a patient developed a pressure ulcer, had a skin breakdown, or had a change for the worse in their existing pressure ulcer, they considered the treatment as a failure. The researchers would then prescribe a specialty bed for the failed participant, and if the bed was a rental, they recorded the cost.

Study Endpoints

The patients would end their participation in the study for several possible reasons:

  • Patient was discharged from the Cardiovascular SICU unit.
  • Patient would develop pressure ulcers, existing pressure ulcers would deteriorate, or skin breakdown occurred.
  • Patient would expire.
  • Patient would withdraw informed consent.
  • Patient completed the total study period consisting of 21 days.
Results of the Study

After the last round of 12 patients, the clinical study ended on January 2010. They published the official results on September 28, 2015.

  • Every single participant (31 patients on the P500 mattress and 21 patients on the standard care mattress) completed the study with no major interruption or incident. Only a single TC500 participant fell from the bed.
  • None of the TC500 bed participants developed new pressure ulcers, while four of the standard bed patients developed new ulcers.
  • They spent a total of $4,116 on rental specialty beds for patients who developed pressure ulcers.

The experiment proved the efficiency of the TC500 bed in preventing the growth or change of pressure ulcers in comparison to the standard care beds used in the ICU unit, as well as the cost-effectiveness of their use.

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