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Direct Supply is proud to introduce the Direct Supply® Panacea® Immerse™ Mattress. The mattress manufacturer has tested the technology used in the Panacea Immerse mattress

to assess its comfort and pressure redistribution properties.

A full study, entitled A Prospective Study of a Unique Open-Cell Foam Mattress with a Modified

Top Layer in Hospitalized General Medical-Surgical Patients, is included for your convenience.

The document has not been evaluated by the Food & Drug Administration. The mattress manufacturer funded all costs associated with A Prospective Study of a Unique Open-Cell Foam Mattress with a Modified Top Layer in Hospitalized General Medical-Surgical Patients. The listed author(s) were compensated by the mattress manufacturer. Third party trademarks and other proprietary information have been removed for purposes of republication.

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The findings show that, when used properly as part of a comprehensive care program, the Panacea Immerse technology did not lead to skin breakdown in patients with intact skin at the time of admission, and improved existing skin integrity in over 75% of patients with existing decubitus ulcers.

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A Prospective Study of a Unique Open-Cell Foam Mattress with A Modified Top Layer in Hospitalized General Medical-Surgical Patients

Glenda J. Motta RN, BSN, MPH, ET

Catherine T. Milne APRN, MSN, BC-ANP/CNS, CWOCN Darlene Saucier APRN, MSN, BC-FNP, CWCN

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Introduction

It is well documented that support surfaces should be used as part of a total program for the prevention and treatment of pressure ulcers.1 Recently released guidelines suggest that the health care professional consider replacing the existing support surface with one that will improve pressure redistribution and microclimate (i.e., heat and moisture control) when a pressure ulcer deteriorates or fails to heal.2

They also recommend that a support surface be chosen to meet the individual’s specific needs based on: 1) the number of pressure ulcers, their severity, and location; 2) the risk for additional ulcers; and 3) the need for additional features, such as the ability to control moisture, temperature, friction, and shear.

Clinicians are advised by the NPUAP guidelines to “evaluate the appropriateness and functionality of the support surface on every encounter.” Unfortunately, in many clinical settings this will not happen for a number of reasons, including inadequate education, staff workload, or availability of alternative surfaces. An ideal support surface would address these issues by providing excellent pressure redistribution and positive outcomes at a reasonable cost.

A new manufacturing process, open-cell visco results in a viscoelastic polyurethane open-cell foam with 40% higher air flow than traditional technology. Modification of the top layer of the mattress generates high levels of pressure redistribution in known high-risk areas, such as the heels and trochanter. When used together in the tested mattress, these two processes produce a support surface superior to traditional viscoelastic mattresses.

An in vivo model using total body pressure mapping of human subjects in supine position compared the tested mattress with conventional foam and bariatric support surfaces. The results demonstrate substantially lower values for average pressure over the entire body surface and maximum pressure measured anywhere on the body. The tested mattress performed from 34% to 65% better than conventional support surfaces and 22% and 37% better than the bariatric mattresses tested (see Figure 1).3

Another study of the tested mattress versus a series of traditional viscoelastic mattresses measured pressure on the left trochanter in healthy volunteers lying in the lateral position. Results showed an average reduction in interface pressure of 49.2% with the tested mattress. In the clinical

situation, this is likely to contribute significantly to reducing the risk of pressure ulcer development in the trochanter, one of the areas of the body most prone to pressure-related problems (see Figure 2).4

Heel ulcers are the second most frequently occurring type of pressure ulcer in the U.S. with an incidence of up to 30% of all pressure ulcers being in this location.5,6 Recent research conducted in healthy volunteers analyzed the level of pinch shear on the occiput and heels where pressure ulcers are common. On the tested mattress peak pressures for both the occiput and the heel were consistently significantly lower than those for standard viscoelastic polyurethane mattresses.7

The literature suggests that viscoelastic foam surfaces may be more effective than the devices classified as Group 1 under Medicare policy.8,9,10 This may be especially true for the tested mattress as pre-clinical studies have shown superior pressure redistribution properties, including average pressure over the entire body surface and maximum pressure measured on areas known to be high-risk for pressure ulcer development.

Figure 2. Comparison of the tested mattress versus Conventional Support Services: Trochanter Major

70

60

50

40

30

20

10

0 1 2 3 4 5 6 7 8 9 10

Conventional Support Surfaces

Peak

Pre

ssu

re (

mm

Hg

)

Test

ed

Mat

tres

s

Figure 1. Peak Pressure

Average Pressure(mm Hg)

Range(mm Hg)

Open-Cell Visco Mattress w/ Modified Top Layer 47.2 ± 6.8 38.0 – 56.0

Conventional 94.2 ± 15.2 78.6 – 119.3

The tested mattress provided an average reduction in interface pressure of 49.2% (range 37.8-58.8)

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Introduction (cont.)

The modification to the top layer is designed to provide a high level of envelopment, defined as the total body area on a support surface at a particular immersion depth. An increase in envelopment ultimately assists in reducing pressure points and provides lower maximum pressures at bony prominences. Tests conducted on multiple volunteers on commercially available conventional and bariatric support surfaces demonstrated that the tested mattress increases the average envelopment by 21% versus the standard viscoelastic mattress and by 15% and 25% versus the bariatric surfaces.11

The range of envelopment for the standard mattresses was 541 to 697 in.2 (average 631 in.2) while envelopment for the tested mattress was 798 in.2. This corresponds with an average performance increase of 21% (13% – 32%) for the tested mattress. The tested mattress versus two standard bariatric mattresses showed a performance increase for the tested mattress of 15% and 20%.

Purpose

In 2009 a new open-cell visco mattress with a modified top layer became available for hospitalized general medical-surgical patients. The purpose of this study was to quantify the impact of this support surface on the incidence of hospital-acquired pressure ulcers (HAPUs) and on ulcers present at hospital admission or time of transfer to the tested mattress in this population.

We addressed two research questions: 1) what is the incidence rate of HAPUs for patients placed on the tested during a 30-day study period? and 2) what impact is there, if any, on healing of ulcers present on admission or at the time the patient is placed on the tested mattress?

The specific objectives of this evaluation were to:• Determine the incidence of skin breakdown for patients

admitted to an acute care hospital and placed on the tested mattress;

• Evaluate wound healing outcomes on patients with pressure ulcers present at admission or at time of placement on the mattress (following transfer from the ICU).

Methods

The setting for the study was a 134-bed acute care community hospital located in central Connecticut. Six new open-cell visco mattresses with modified top layer were placed on existing bed frames in patient rooms located in one general medical-surgical unit.

Prior to initiating the study, the Principal Investigator provided mattress specifications, engineering drawings, fire safety data, pressure mapping study results, and other clinical data to nursing administration personnel and the hospital purchasing director for review. The nursing research manager determined that IRB approval was not required to conduct the evaluation.

Once staff were informed of the study parameters, patients were randomly placed on the surface upon admission to the facility or when transferred from the ICU. The time frame for the evaluation was 30 days. All patients placed on the six mattresses during the study period were evaluated. Data on diagnosis, sex, age, height, weight, body mass index (BMI), Braden scores, PUSH Tool scores, skin assessment, and length of stay were recorded for all patients. In addition, clinician observations and patient comments regarding moisture control, comfort, functional ability and other benefits were documented.

Data Analysis Fifty-four (54) patients (33 males; 21 females) participated in the study; no patient was excluded from participation or analysis. Ages ranged from 39 to 99 years (mean 67.4 years). Hospital length of stay varied from two to nine days (mean 3.87 days). On admission, Body Mass Index (BMI) recordings ranged from 14.3 – 49.9 (mean 27.5). The BMI percentage breakdown was: 5.6% underweight; 31.4% normal weight; 29.6% overweight; and 33.4% obese. Braden Scale scores on admission ranged from 9 to 23 (mean 17.5). Nine (9) patients scored moderate risk or higher; 32 were mild risk and 13 low or no risk. The scores at discharge remained very similar (mean 17.6; range 8 – 22).

Skin assessment at admission/time of placement on the mattress identified 13 patients (20.3%) with altered skin integrity; 5 of these (9.2%) had pressure ulcers. The remaining were 4 skin tears, 2 cases of irritant dermatitis, 1 surgical incision, and 1 case of cellulitis from a dog bite.

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Data Analysis (cont.) The five patients with pressure ulcers present at hospital admission or the time of transfer to the tested mattress had a total of nine ulcers, classified as follows:• Patient #1: Stage II sacral; Stage II each buttock (three ulcers)• Patient #2: Stage IV heel• Patient #3: Stage I sacral• Patient #4: Stage I ulcers: sacral; right and left sacroiliac

(three ulcers)• Patient #5: Stage II heel

Results

The first objective of this study was to determine the incidence of skin breakdown for patients admitted to an acute care hospital or transferred from the ICU and placed on the tested mattress. The 41 subjects who had intact skin at admission or at the time placed on the surface had no new skin breakdown at discharge. The 13 patients with existing altered skin integrity also had no new breakdown. Thus, the incidence of hospital-acquired pressure ulcers and skin breakdown for all 54 patients in the study was zero.

The second aim of the study was to evaluate wound healing outcomes on patients with pressure ulcers present at admission or at time of placement on the mattress (following transfer from the ICU). Of the 13 patients with existing altered skin integrity, 76.9% (n=10) improved. The incidence of new pressure ulcers in this population who were at greater risk for the development of a pressure ulcer was zero.

It is interesting to note that 2 patients admitted to the general medical-surgical unit for hospice care had Kennedy Terminal Ulcers (KTUs) and the staff anticipated additional skin breakdown and/or new pressure ulcers. Not only were there no new ulcers, but the existing wounds did not deteriorate.

The following is a summary of wound healing outcomes documented at discharge:• Mean PUSH Tool score: 5.1 (range 2 – 9)• Patient #1: 3 pressure ulcers healed • Patient #2: Stage IV decreased in size by 0.2 cm (length

and width)• Patient #3: skin intact at discharge• Patient #4: 3 ulcers no improvement, no worsening, no

new ulcers (hospice)• Patient #5: heel ulcer no improvement, no worsening, no

new ulcers (hospice)

Observations from both the clinicians and patients on mattress benefits, such as moisture control, comfort, ease of transfer and functional mobility were recorded as well. Clinicians reported that there were no moisture pools under patients commonly seen with the air overlay/foam mattress combination currently in use. Patients noted that this mattress was more comfortable than any other in the hospital and felt like a bed at home. They also indicated that it allowed their best night of sleep ever experienced in a hospital. One patient even refused to get up for therapy because the bed was so comfortable.

Especially noteworthy were the comments from physical therapists who noted that patients on the tested mattress found it easier to transfer out of bed, resulting in greater compliance with therapy. Little has been documented on the impact of various support surfaces on patient mobility. Pressure redistribution surfaces are commonly ordered based on risk assessment scores with no consideration for functional mobility goals.

As a result of the outcomes documented in this evaluation physical therapists later collected mobility rating data on the tested compared to the currently used foam mattress with static overlay. Both physical therapists and patients rated the ability to move on the tested mattress as much as 36% higher.12

Notable Findings• 75% of patients had a Braden scale score of <18 and

thus, were at risk• There was zero incidence of new pressure ulcers for

all patients• Five individuals had pressure ulcers on admission;

4 improved and 1 remained unchanged • Hospital staff reported greater ease of turning

and transfer and increased patient mobilization as compared to surfaces used under current protocol

• P.T. reported improved patient compliance with physical therapy

• All patients reported positively regarding comfort

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Data Summary

Demographics

• 54 patients used one of six identical mattresses over a 30 day period.

• Sex: 33 males; 21 females

• Mean age: 67.4 (range 39 -99)

• Mean length of stay: 3.87 days (range 2 – 9)

• 2 patients expired as was expected (i.e., were admitted as hospice care)

Body Mass Index

• Mean BMI: 27.5 (range 14.3 – 47.9)

• Percentage underweight as determined by BMI: 5.6%

• Normal weight: 31.4%

• Overweight: 29.6%

• Obese: 33.4%

Braden Scale Scores

• Mean on admission: 17.5 (range 9–23)

• Low or no risk: >18 (n=13)

• Mild risk: 15–18 (n=32)

• Moderate risk: 13–14 (n=7)

• High risk: 10–12 (n=1)

• Very high risk: <9 (n=1)

• Mean on discharge: 17.6 (range 8 – 22)

Admission Skin Assessment

• Skin integrity altered at time of placement on mattress: 20.3% (n=13 patients)

• Type of skin integrity alteration: pressure ulcers (n=5), venous leg ulcers (n=1), surgical incisions (n=2), skin tears (n=2), irritant dermatitis (n=2), cellulitis from dog bite (n=1)

Pressure Ulcer Data

• Pressure ulcers on admission: 9.2% (n=5 patients with 9 pressure ulcers)

• Patient #1: Stage II on sacrum; Stage I on each buttock (total of 3 ulcers)

• Patient #2: Stage I ulcers: sacrum, right and left sacroiliac (total of 3 ulcers)

• Patient #3: Stage II on heel

• Patient #4: Stage IV on heel

• Patient #5: Stage I on sacrum

• Mean Pressure Ulcer Scale for Healing (PUSH Tool) score: 5.1 (range 2 – 9)

• 1 patient with 3 pressure ulcers: healed

• 2 patients: ulcers improved by discharge

• 2 patients: pressure ulcer showed no improvement but did not worsen as expected (hospice patient)

• Most impressive result reported by nursing staff: 99 y.o. dying patient admitted with 3 Stage I pressure ulcers; no fluid intake; hypotensive; Braden score declining daily; on MS drip for pain

• No worsening of existing pressure ulcers that were considered to be Kennedy Terminal Ulcers (KTUs) in hospice patients

• No new ulcers developed

Discharge Skin Assessment

• Did skin intact on admission remain so at discharge? Yes, for 41 subjects with skin intact on admission

• Was skin with altered integrity improved at discharge? 20.3% (13 patients) admitted with altered integrity; 10 of these improved at discharge

• Did patient develop alteration in skin integrity while hospitalized? None of 54 patients developed alteration in skin integrity during one-month trial

• All patients reported positive comments regarding comfort. Staff reported greater ease of transfer, turning and improved patient mobilization/mobility as compared to traditional surfaces

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Data Summary

Mild risk 15-18 (n=32)

Low or no risk >18 (n=13)

Moderate risk 13-14 (n=7)

High risk 10-12 (n=7)

Very high risk <9 (n=7)

Mean risk level on admission 17.5 (range 9-23),Mean risk level on discharge 17.6 (range 8-22)

BRADEN SCALE SCORES / RISK LEVEL

77%showed significant

improvement

23%showed no

improvement

Of the 23% of patients who suffered from a skin integrity alteration at time of admission, 77% improved by discharge.

PUSH (PRESSURE ULCER SCALE FOR HEALING)- ALTERED SKIN INTEGRITY PATIENTS

80%healed or showed

significant improvement

20%remained

unchanged

Of the close to 10% of patients who were admitted with pressure ulcers, 80% healed or showed significant improvement and 20% remained unchanged.

PUSH (PRESSURE ULCER SCALE FOR HEALING)- EXISTING PRESSURE ULCER PATIENTS

33 males

21 females

54 patients used one of six identical mattresses over a 30 day period.

DEMOGRAPHICS

Normal31.4%

Underweight 5.6%

Overweight29.6%

Obese33.4%

Mean BMI 27.5 (Range 14.3- 47.9)

BODY MASS INDEX

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Discussion

The community hospital in which this study was conducted has had a comprehensive pressure ulcer prevention program in place since 1992. The prevalence of pressure ulcers on this unit calculated using quarterly data from 2005 to present has ranged from 0 – 12.2%, with an average of 0.8% The prevalence was 2.8% during the quarter that this study was conducted. In the previous three years, no new stage III or IV ulcers had been reported for patients on this general medical-surgical unit utilizing the current static air overlay/foam mattress protocol.

The outcome of zero incidence of HAPUs during this evaluation is significant even with this history. New support surface technology is available that may allow this hospital and others with such programs in place to achieve even better patient outcomes at lower cost.

Our results are especially meaningful in terms of the national incidence rates of HAPUs, current initiatives to improve healthcare outcomes and quality-based payment systems. Incidence rates of pressure ulcers range from 0.4% to 38% in acute care.13 The national incidence benchmark for the hospital setting (based on 2004 data) is 7%.14

A recent report to the Congress on Medicare’s role in supporting and motivating quality improvement notes a wide variation in U.S. quality of healthcare and that the pace of improvement has been “frustratingly slow.”15 In 2006 there were 322,946 reported cases of Medicare patients with a pressure ulcer as a secondary diagnosis.16 Medicare has multiple ways to induce quality improvement. One of the most powerful is through payment incentives. Acute care hospitals now function under a Quality Incentive payment program in which payments are based on quality performance indictors.

One component Medicare uses to assess quality of care provided in hospitals is Patient Safety Indicators (PSIs), the incidence of potentially preventable adverse events resulting from inpatient care. The most common adverse event reported by CMS in 2007 was “decubitus ulcers”.17

This, coupled with the fact that the incidence (the number of patients who develop a pressure ulcer after admission to a hospital) remained steady at approximately 7.6% from 1999-2004, calls into question the effectiveness of support surfaces currently in use.18

Healthcare professionals and purchasing agents continue to rely on studies that primarily address interface pressure readings to select support surfaces. Unfortunately, many other factors contribute to pressure ulcer development, including temperature, moisture, inability to reposition, ulcers on multiple turning surfaces, shear forces, and friction. An ideal surface will address as many of these factors as possible.

One panel of authors noted that correlating the interface pressure measured for various support surfaces with relevant prevalence or incidence information will be useful in understanding the role of pressure in reducing pressure ulcers and the effectiveness of these surfaces.19 Consequently, the aim of this study was to obtain incidence data that could be correlated to documented interface pressure measures for the tested mattress.

Based on previous reported evidence and the findings of this evaluation that patients with existing pressure ulcers showed evidence of improvement, the tested mattress may warrant classification as a Group 2 support surface under Medicare guidelines. Further study is indicated to support Medicare requirements for classification into this category.

Conclusions

While this facility’s documented incidence of HAPUs is well below the national benchmark, the staff concluded that for patients with a Braden Scale score of ≤ 18, the tested mattress alone is as effective, if not more so, than the current combination product protocol (foam mattress plus static air overlay) used for patients with these scores. Eliminating the current protocol has the potential to significantly reduce costs for this hospital, critical for success in today’s challenging reimbursement climate.

Pressure ulcers delay recovery and hospital discharge. In addition, a hospital-acquired pressure ulcer is considered a nurse-sensitive outcome and a reflection of the quality of care rendered. HAPUs cost the U.S. Healthcare System $2.3 to $3.6 billion annually and result in significant mortality. Hospitals are challenged to prevent acquired pressure ulcers to improve outcomes and revenue flow. Based on our findings from this prospective study, the tested mattress can help keep hospitals profitable with proven outcomes and qualifies as a valuable aid in meeting national quality initiatives.

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References1. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice

Guideline Number 3. AHCPR Publication No. 92-0047. Rockville, MD: Agency for Health Care Policy and Research; May 1992.

2. European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel. Prevention and treatment of pressure ulcers. Washington DC: National Pressure Ulcer Advisory Panel; 2009.

3. Hermans MHE, Warren ST, McCabe K, et al. Variable pressure foaming Surface Modification Technology in polyurethane systems show a clear reduction of pressure in an in vivo test model. Poster. SAWC Fall 2009.

4. Hermans MHE, Warren ST, Neto M, Reger SI. Evaluation of a new mattress technology by mapping the pressure on the trochanter major in healthy volunteers. Poster. SAWC April 2010.

5. Cuddigan J, Ayello EA, Sussman C, Baranoski S. Pressure ulcers in America: prevalence, incidence, and implications for the future. National Pressure Ulcer Advisory Panel 2001; Reston, VA.

6. Hunt DR, Verzier N, Abend SL, et. al. Fundamentals of Medicare patient safety surveillance: intent, relevance, and transparency (unpublished data). Centers for Medicare and Medicaid Services 2005; Baltimore, MD.

7. Hermans, MHE, Neto M, Warren S. Measuring pinch shear forces on the occiput and the heels using pressure mapping: results of a study in volunteers. Poster. SAWC Spring 2011.

8. Krapfl, LA, Gray, M, Does regular repositioning prevent pressure ulcers? J WOCN. 2008; 35(6): 571-577.

9. Price, MC, Whitney, JD, King CA. Development of a risk assessment tool for intraoperative pressure ulcers. J WOCN. 2005; 32(1): 19-30.

10. Defloor, T, De Bacquer, D, Grypdonck, MHF. The effect of various combinations of turning and pressure reducing devices on the incidence of pressure ulcers. Int J Nurs Studies. 2004; 42:37-46.

11. Hermans MHE, Neto M, Warren S. Surface Modification Technology results in an increase in envelopment in pressure redistribution mattresses. Poster. WCET/WOCN June 2010

12. Warner E, Montague D, Zinko M. Physical therapist and patient mobility on two pressure redistribution surfaces. Poster. SAWC April 2011.

13. Lyder CH. Pressure ulcer prevention and management. JAMA. 2003; 289(2):223-226.

14. Whittington KT, Briones R. National prevalence and incidence study: 6-year sequential acute care data. Adv Skin Wound Care. 2004;17(9):490–494.

15. Medpac. Report to the Congress: Aligning incentives in Medicare. Jun 2010.

16. Institute for Healthcare Improvement. Relieve the pressure and reduce harm. May 21, 2007.

17. Medpac. Report to the Congress: Medicare payment policy. Mar 2009.

18. Whittington op. cit.

19. Reger, SI, Ranganathan VK, et al. Support surface interface pressure, microenvironment, and the prevalence of pressure ulcers: an analysis of the literature. Ostomy Wound Manage. 2008; 54: 50-58.

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