ADERMA DERMAL PADS in prevention & reduction of pressure injuries

Tissue Viability Consultancy Services

REPORT OF A CLINICAL EVALUATION: ADERMA DERMAL PADS in prevention & reduction of pressure injuries

ANNA COULBORN TVN RGN DEBBY VERRALL TVN HCA

December 2010

Report on Adermal Pad Evaluation

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1) EXECUTIVE SUMMARY 

The Aderma Dermal Pads were evaluated by 4 Subjects in a Nursing Home over a 28 day period, in order to examine its effect on contributing to the prevention of pressure damage. Unfortunately 1 of the Subjects died prior to our second visit to the home so has been omitted from the study. The average age of the Subjects was 90 years, with the oldest Subject being 96 years old and the youngest Subject being 85 years old.

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The Waterlow Score Range was 15 – 27, with the average Waterlow Score being 19. Therefore all Subjects were in a `High Risk` to `Very High Risk` category (appendix 1). The Subjects and Nursing Home Staff all reported that the Aderma Pads provided increased comfort and some were not aware of the pads being in place.

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All Subjects had existing pressure damage prior to the use of the Aderma Dermal Pads on either the sacrum or their heels. Use of the Aderma Pads appeared to result in improvement in the tissue viability of the Subjects both visually, and via High Definition Ultrasound Scan.

2) INTRODUCTION Preventing pressure damage is difficult, due to the large number of potential aetiological factors involved, although it is recognised that the largest single factor is unrelieved pressure. Concomitant to this are other predisposing factors which may be intrinsic or extrinsic. These include, intrinsically malnutrition, incontinence, altered level of consciousness and altered level of sensation. Extrinsically there are shear and friction forces (appendix 2). Many of these factors are often involved simultaneously and for these patients who are confined to bed for long periods, appropriate pressure redistributing equipment needs to be considered.

3) ADERMA DERMAL PADS The Aderma Dermal Pads are a new product marketed by Focus Products Developments.

The Aderma Pads are designed to `reduce and redistribute pressure away from critical areas` to `transfer frictional force away from the skin` to `change shape with natural movement of the body` to be ` washable and reusable on individual patients` and to be `similar to fatty tissue` in potential for protection of vulnerable tissues.



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4) AIM OF STUDY To evaluate the clinical efficacy of the Adermal Dermal Pads on a small group of Nursing Home Subjects, when used in conjunction with their existing mattresses and Cushions.

5) METHODOLOGY The Subjects for the study were residents in a Nursing Home, each of whom had existing pressure damage no greater than Grade 1 (EPUAP Grade, appendix 3). Prior to the evaluation, the Subjects had been identified by Nursing Home staff as being at high or very high risk of pressure damage. 2 Subjects were given the Aderma Sacral Pads and 1 subject was given the Aderma Heel Pads. All 3 were given spare products to enable cleansing of the Aderma Pads. Subjects Profiles All Subjects had a profiling bed and the mattress provision was deemed appropriate for their needs, as was the cushion provision. 2 out of the 3 Subjects required hoisting out of bed. All 3 of the Subjects were completely continent or Catheterised. All of the Subjects had a good nutritional intake with a MUST Score of 0. The Subjects were visited prior to the commencement of the study, in order to collect demographic data. DAY 0 All Subjects remained in bed prior to assessment. The skin of each Subject was examined for signs of pressure damage (redness and heat). Photographs were taken of sacral region and heels that exhibited any of these signs of pressure damage. A High Definition Ultrasound Scan was taken of either the sacrum or the heels of each of the Subjects. The Aderma Dermal Sacral and Heel Pads were applied to the patients. DAY 10 & DAY 28 The above methodology was repeated as above apart from on Day 10 photographs only were taken. On Day 10 it was noticed that 1 of the Heel Pads was showing signs of splitting as was 1 of the Sacral Pads so the spare Pads were applied (Fig 1). It is not known if the split was caused by poor management of the product by the nurses. All other Aderma pads remained in tact. Report on Adermal Pad Evaluation

Figure 1


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6) RESULTS The skin on all 3 subjects showed marked signs of improvement both visually and on the High Definition Ultrasound Scan. The improvement was seen on Day 10 and on the final evaluation Day 28. All 3 Subjects were scanned at Day 0 and Day 28. Although one of the Aderma Pads split it was not deemed detrimental to the sacral or heel pressure areas as new Pads were able to be put in place immediately. Subjects 2 and 3 were not aware that they had the Sacral Aderma pads in situ and all 3 subjects stated that their comfort levels were greatly improved. The individual case studies, with photographs, are presented at the end of this report.

7) CONCLUSION It must be appreciated that the above results, whilst extremely positive, only apply to a very small group of individuals and a larger study may be indicated. However all 3 Subjects had exhibited visual evidence of pressure damage during the initial assessment on Day 0. All the Subjects skin showed significant improvement on Day 28.

8) EVALUATION

Subject 1 (BS) 89 year old female Waterlow Score of 15 Medical History: Urinary Tract Infections, Anaemia and Osteoporosis Average number of hours spent out of bed: 12 hours Aderma Heel Pads were applied

Day 0 Fig 2 shows marked erythema of the right heel with oedema being present

Fig 2



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Day 10 Fig 3 shows the visual improvement at day 10 and less oedema noted

Fig 3 Day 28 Fig 4 shows some erythema is still present but the High Definition Ultrasound Scan does show there is no oedema left on the right heel

Fig 4



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Subject 2 (DC) 85 year old male Waterlow Score: 16 Medical History: Left Cardio Vascular Accident, Average hours spent out of bed: 10 hours Aderma Dermal Sacral Pads applied

Day 0 Fig 5 shows marked blanching erythema to the sacrum as grade 1 pressure damage

Fig 5

Day 10 Fig 6 shows there is slightly less erythema present

Fig 6 Day 28 Fig 7 at the end of the evaluation the sacral region shows a marked improvement



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Subject 3 (VW) 96 year old female Waterlow Score 27 Medical History: Urinary Tract infection, Cerebral Vascular Accident, Hypertension Average number of hours spent out of bed: 8 hours Aderma Dermal Pad Sacrum applied

Day 0 Fig 8 shows the non-blanching erythema present in the sacral region

Fig 8 Day 10 Fig 9 shows a reduction in the amount of erythema present, which is now blanching

Fig 9 Day 28 Fig 10 shows very little erythema present now in the sacral region

Fig 10 Report on Adermal Pad Evaluation


Aderma Pad Ultrasound Analysis


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Aderma Pad Ultrasound Analysis Trial Design This pilot study was carried out by TVCS in Eastbourne on patients with evidence of pressure damage. 4 Patients were initially recruited for this trial, unfortunately 1 patient died midway through the trial, and therefore data from 3 patients will be included in this report. The trial design was as follows: Visit 1 

Patients identified and consented.

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Ultrasound scan carried out on damage area to establish a baseline. Also, an area of normal skin adjacent to the damaged area was scanned to ascertain what the patient’s uninjured skin looked like.

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Patients were then assigned an Aderma Pad to be used on the affected area.

Visit 2 

4 weeks after the baseline visit the damage areas were again scanned. From the information gained from this it was possible to establish if the area had improved, deteriorated or stagnated.

Assessment:

Ultrasound Scanning: The benefit of including ultrasound as an assessment tool is that it provides quantitative information about what is happening beneath the skin surface which is not always clinically evident (1-6). The scanner used in this project (figure 1) operated at a frequency of 20MHz (Episcan Longport Inc.). This frequency gives an axial resolution of 65m.



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Figure 1. Ultrasound Scanner

The scanning procedure is non-invasive and the affected area was exposed and an aqueous gel applied to it and a scan then taken.

Care was taken to carry out subsequent

scans in the same area. Scans were also taken of the patient’s normal skin adjacent to the affected area to get a profile of what the patient’s uninjured skin should look like. Scans of the injured skin was then compared to the scans of the ‘normal’ skin (fig 2) to give us a measure of how far from normal the tissues were at the start of the study and how they then progressed back towards the normal profile as the study advanced.

Scan Analysis Using the scanners image analysis software it was possible to measure the amount of oedema within the dermal tissue. Each scan of the tissue was analysed using a form of pixel distribution analysis whereby pixels below certain intensity are classed as Low Echogenic Pixels (LEP). The ratio of LEP’s to Total Pixel count (TP) has been shown to reflect changes in dermal water content (7, 8). Using this technique it was possible to get a quantitative assessment of the level of oedema present in the damaged tissue.



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Figure 2 scan of normal skin with adjacent histology section indicating zones

Results – DC (Sacrum) The results of the scans show that as time progressed the damaged area moved towards a more normal skin profile as inflammation started to subside and oedema moved out of the area. The figure below is a typical example of this.

Figure 3. Scans comparing the patient’s normal skin with the damaged site.

Normal Uninjured Skin


Injured Sacrum - time 0


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Injured Sacrum 4 weeks It can be seen from the scans that the normal skin dermis is mainly composed of fibrous tissue which ultrasonically is shown as mainly blue pixels. Compare this to the injured tissue at time 0 which has a large number of red pixels in the scan. This is a typical profile of an oedematous tissue. The scan of the same tissue after 4 weeks shows that there is a decrease in red pixels and an increase in blue pixels which indicates a movement back to the uninjured state. Figure 4 Graph of LEP: TP ratio for DC Sacral Analysis

The graph above shows that the LEP:TP ratio after initially moving away from normal uninjured levels returns back to normal levels within 4 weeks after starting therapy.



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Results – BS (Heel)

Figure 5. Scans comparing the patient’s normal skin with the damaged site. Normal uninjured right heel skin

Injured right heel time 0

Injured right heel 4 weeks

The injured tissue at time 0 has a large number of red pixels in the scan indicating the presence of oedema. The scan of the same tissue after 4 weeks shows that there is a decrease in red pixels and an increase in blue pixels which indicates a movement back to the uninjured state.



Normal uninjured left heel skin

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Injured left heel time 0

Injured left heel 4 weeks

This patient’s left heel is not as oedematous as the right heel; however, we can still see an area of oedema collecting at the dermo-epidermal junction. oedema has resolved.


By 4 weeks this area of


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Figure 6 Graph of LEP: TP ratio for BS Heel Analysis

The first point to note from the graph above is that left and right side uninjured tissues are not identical. The left side has a higher ratio value than the right. The second point to note is that the injury to the right heel is worse than that to the left, as shown by the higher ratio value at time 0. By 4 weeks after starting the therapy the right heel ratio level has almost returned to that of the original uninjured tissue. The left heel has not appeared to have changed significantly over the 4 week period, however, this may be due to the fact that this heel was not as oedematous as the right heel initially at time 0 and therefore not as badly injured.



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Results – VW (Sacrum) The results of the scans show that as time progressed the damaged area moved towards a more normal skin profile as inflammation started to subside and oedema moved out of the area leaving. The figure below is a typical example of this.

Figure 7. Scans comparing the patient’s normal skin with the damaged site.

Normal Uninjured Skin

Injured Sacrum 4 weeks

Injured Sacrum - time 0

It can be seen from the scans that the normal skin dermis is mainly composed of blue pixels. Compare this to the injured tissue at time 0 which has a large number of red pixels in the scan. This is a typical profile of an oedematous tissue. The scan of the same tissue after 4 weeks shows that there is a decrease in red pixels and an increase in blue pixels which indicates a movement back to the uninjured state.



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Figure 8 shows the results of the pixel analysis. Figure 8 Graph of LEP: TP ratio for VW Sacral Analysis

The graph above shows that the LEP:TP ratio after initially moving away from normal uninjured levels returns back to normal levels within 4 weeks after starting therapy.

Conclusion The results of the ultrasound scan analysis show that the treatments appear to be having an effect on tissue recovery. However, it should be understood that this is a pilot study with only three patients and that limited 4 week observation period may not have been long enough to see the full effect of the treatment. It is recommended that the study should be expanded both in terms of patient number and length of study period to achieve statistically significant data.



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References 1.

Young SR, Ballard K. Wound Assessment: Diagnostic and assessment applications – Part 2.. In: Electrotherapy-Evidence based practice 2001. Pp308-312. ChurchillLivingstone (London).

2.

Chen L. Dyson M, Rymer J, et.al. The use of high frequency diagnostic ultrasound to investigate the effect of HRT on skin thickness. Skin Research And Technology 2001; 7(2): 95-7

3.

Mirpuri N, Young SR. The use of diagnostic ultrasound to assess the skin changes that occur during normal and hypertensive pregnancies. Skin Research and Technology 2001; 7:63-69.

4.

Kerr A, Young S, Hampton S. Has packing sinus wounds become a ritualistic practice? British Journal of Nursing 2006; 15(19): S27-S30.

5.

Quintavalle P, Lyder CH, Mertz PJ, et.al. Use of high-resolution, high frequency diagnostic ultrasound to investigate the pathogenesis of pressure ulcer development. Adv. Skin & Wound Care 2006; 19(9):498-505.

6.

Young S, Bolton PA, Downie J. Use of high-frequency ultrasound in the assessment of injectable dermal fillers. Skin Research and Technology 2008;1 14: 1-4.

7.

Gniadecka M. Localization of dermal edema in lipodermatosclerosis, lymphedema, and cardiac insufficiency: high-frequency ultrasound examination of intradermal echogenicity. J Am Acad Dermatol. 1996; 35:37-41. Gniadecka M, Quistorff B. Assessment of dermal water by high-frequency ultrasound: comparative studies with nuclear magnetic resonance. Br J Dermatol. 1996; 135:218-224

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APPENDIX 1 WATERLOW SCORE CHART



BODY MASS INDEX BMI 20 - 24 (average) BMI 25 - 29.9 (medium) BMI 30 - > 40 (large) BMI 15 Kg UNSURE

3 4 2

0 1


 SPECIAL RISKS

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1 2 1 2

TISSUE MALNUTRITION TERMINAL CACHEXIA CARDIAC FAILURE PERIPHERAL VASCULAR

 8 5

3 4

DISEASE ANAEMIA

5 2

5

SMOKING

1

 NEUROLOGICAL DEFICIT 0 eg DIABETES, MS, CVA, 1 MOTOR/SENSORY PARAPLEGIA 2 MAJOR SURGERY/TRAUMA ORTHOPAEDIC 3 BELOW WAIST, SPINAL 

CYTOTOXICS, HIGH DOSE STEROIDS, ANTIINFLAMMATORY

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NUTRITION SCORE If > 2 refer for nutrition assessment/intervention

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Score 10+ At Risk 15+ High Risk 20+ Very High Risk

 4-6 4-6 5  5


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APPENDIX 2 BACKGROUND INFORMATION Pressure ulcers occur when pressure is applied to the same area of the body for an extended length of time. This prevents blood travelling to the area and restricts the flow of oxygen, causing body tissue to die. This forms into a wound which is commonly referred to as an ulcer or a sore. Before the pressure ulcer becomes a break in the tissues, there are several grades through which damage will progress. Each of these can act as a warning to any observant and reasonable nurse and all nurses have been taught how to assess for pressure damage early in their training as nurses. Each of these grades can be seen demonstrated in appendix 6. The first stage to be seen is a non-blanching erythema or a redness that does not turn white when pressed. At this stage, damage is almost always reversible if attended to immediately it is noted. This means that equipment or something is used to reduce the pressure that is causing the problem. If carers are trained to note this stage and to report, then further damage may be avoided by intervention with appropriate equipment. The second stage is a break in the skin. This is most likely caused by friction or shear forces where the tissues are rubbed against a harder surface and often become pinched. Although this damage can be great, it is more often a superficial blistering or friction burn. However, when direct pressure AND shearing occurs together, then the damage can be extremely severe. The next 2 grades are due to unrelieved pressure and can be as deep as to the bone. Due to the greater pressure being close to the bone – away from the surface tissues, the greatest damage is against the bone and the lesser damage is on the surface. This is known as the cone of pressure. These grades expose muscle (grade 3) and bone (grade 4) and are often full of necrotic (dead) tissue and are life threatening as the dead tissue is a breeding ground for pathogenic bacteria that can cause systemic clinical infection or can cause toxins to poison the system. However, all of the above begin as a redness and, therefore, redness acts as a warning that pressure damage is occurring. All nurses are taught these stages and each nurse has access to the N.I.C.E. and EPUAP Pressure Ulcer Prevention Guidelines which recommend how the redness can be prevented in becoming irreversible damage. Pressure ulcers are 95% preventable (Hibbs, 1984) and the 5% that are not preventable are due to either the damage being caused before the patient is admitted into hospital or is due to the extreme morbidity of the patient. Pressure ulcer causes can be identified through time of development and site of development. For instance, a pressure ulcer on the ischial tuberosity can only be caused by sitting too long on a chair, as when in bed, the pressure site is transferred to the sacrum, hip or buttocks.



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APPENDIX 3 EUROPEAN PRESSURE ULCER ADVISORY PANEL (EPUAP) GRADING SCALE FOR PRESSURE INJURIES



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Pressure Injury Grading

Grade 1 pressure injury. Unbroken skin but a redness caused by prolonged pressure. Will be found over bony prominences such as hip, sacrum or under the buttocks.

Grade 2 pressure injury. There will be a blister or scraze. Generally caused by sliding down in bed or chair or through poor manual handling techniques.

Grade 3 pressure ulcer. Exposes muscle. Easily infected. Often does not show the true extent of the wound which can be hidden beneath surface tissues – like an iceberg.

Grade 4 pressure injury extends to bone. This is a particularly dangerous stage as it is infective necrosis – contains anaerobes and the patient usually becomes clinically unwell. Can be sited as cause of death in many instances.
