Skin damage associated with incontinence devices

Mandy FaderProfessor or Continence Technology

Faculty of Health SciencesUniversity of Southampton

UK

Medical Devices and Skin vulnerability sandpit

Background

• Are unable to be (fully) cured.• Are awaiting treatment.• Are waiting for treatment to take effect.• Elect not to pursue cure options.

Continence products are essential in enhancing the quality of life of those with bladder and/or bowel leakage who:

http://www.spinal.co.uk/help/Anal_plug3.jpghttp://www.spinal.co.uk/help/Anal_plug3.jpg

Prevalence and costs (UK)• Around 400,000 NHS pad users

• £96 million pa (CF 2000)

• Around 40-50,000 ICath users• £60 million pa (PCA 2009)

• Around 50,000 LTCath users• £20 million pa (PCA 2009)

• Around £20 million pa other products• DH Prescription cost analysis (PCA 2009)

http://www.spinal.co.uk/help/Anal_plug3.jpghttp://www.spinal.co.uk/help/Anal_plug3.jpg

Products for managing toileting, urinary retention, UI and FI

UrinalsToileting aids

Pads Catheters

Body-worn urinalsFI devices

Sheaths

Bags Mech. devices

Skincare & odour products ?

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Absorbent pads

Washable productsDisposable insert

Disposable diaper/AIO

Disposable T-shaped diaper

Disposable pull-ups

PresenterPresentation NotesMention underpads

Insert Diaper /AIO Pull-up T-shapeWash-able

Men 284 347 303 355 431

Women 147 203 176 186 311

N (pads) 1943 2196 2066 1426 819

Median urine mass per pad (g)

Healthy skin

Compromised skin Incontinence-associated skin damage

Aetiological factors:•Faecal enzymes•Mechanical action (friction, shear, pressure)•Chemical irritation (topical products)

Clinical interventions to:• Prevent water penetration(e.g.barrier products,pad changing improved pads)• Minimise faecal contact• Prevent irritation (low irritant cleansers)• Reduce friction (shear/pressure)• Reduce inflammation (topical

creams/medication)

Environment within wet pad:• Skin over-hydrationIncreased skin permeabilityHigher skin friction coefficient Lower skin abrasion resistanceGreater microbial load Increasing pH

Model of incontinence-associated skin damage (based on Berg 1986)

M Fader, S R Clark-O'Neill, W K R Wong, B Runeman, A Farbrot and A M Cottenden. Review of methods used for quantifying excess water in over-hydrated skin using evaporimetry (Skin Research and Technolog February 2010 16, (1 ) 1-8.

Development and preliminary testing of a standardized method for quantifying excess water in over-hydrated skin using evaporimetry. Physiological Measurement 2011, 32 305-317.

Evaporimeter

Desorption curve for drying skin

PresenterPresentation NotesIn my post-doctoral work I focused on developing a reliable method for measuring the amount of water in the skin using an evaporimeter which measures water evaporating from the skin. Difficult measurements to take, needed be made in an environmentally controlled room and took a couple of hours to complete. Experiments could be ruined by movement – so we had to encourage patients not to talk and set up a film for them to watch. Now this film was Notting Hill – mildly amusing but not laugh out loud except when the welsh guy opens the door with no clothes on – and the timing meant we never got to that bit - so there are scenes in Notting Hill which I can recite and act out for you. These are the measurements that we made and we measured the area under the curve to calculate the water in the skin. Why is this important – well

Protecting skin from wet pads

Apply cream

Wear saline-soaked patch

for 20 min

Monitor SSWL for 10 min

10 subjects, one measurement per treatment + control

Peak pressures (SD) recorded from three mattresses (standard, visco-elastic, surface-cut foam)under three conditions (naked, dry pad, wet pad)

Pad condition

naked dry pad wet pad

Pres

sure

mm

Hg

50

60

70

80

90

100

110

Standard foamVisco-elastic foamSurface-cut VE foam

Unsmoothed pad on standard foam mattress

90-10080-9070-8060-7050-6040-5030-4020-3010-200-10

Fader M, Bain D, Cottenden A Effects of absorbent incontinence pads on pressure management mattresses. J Adv Nurs. 2004 Dec;48(6):569-74.

PresenterPresentation NotesAs part of this work I was also very interested in understanding the effects of pressure which can cause pressure ulcers on skin health and did some experiemental work using a phantom or manequin wearing an incontinence pad to find out whether they increased the presssure – which we found that they did.

Chart1

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Buttocks wearing a dry pad on standard foam mattress (mm Hg)

Products and devices for men

Mechanical devices

Indwelling cathetersPads

Body-worn urinals

Sheaths & bags

?

http://www.rpdinc.com/assets/images/W467-485-A.gifhttp://www.rpdinc.com/assets/images/W467-485-A.gif

Sheath

Body-worn urinals

Device briefs

02

In partnership with

Penile compression devices (clamp)

Design differencesfor key performance characteristics

N=56% = proportion of men rating as ‘good’ or ‘acceptable’ v ‘poor’ and = designs performed significantly better or worsethan one, two or all other designs (p=0.05)

Pad%

Sheath%

BWU%

Clamp%

% reporting – No leak 21 49 36 75

% reporting - No smell 38 69 53 70

% reporting - Feels secure 46 38 32 68

% reporting – Can wear any clothes 38 42 38 68

% reporting - No pain 75 58 35 11

% reporting - Comfortable (dry) 77 64 38 n/a

% reporting - Easy to put on 84 43 25 51

16

Measuring skin damage from clamps

• Laser doppler• Sebutape - inflammatory markers• Interface pressure sensors

Methods

Loading scheme

Flat Clamp

Angled Clamp

Contoured Clamp

Contoured with Knob

• 12 model variants were developed,representing five generic designs ofincontinence clamps and threestiffnesses of interface materials

• Opposite vertical displacements wereassigned to the top and bottom surfacesof every clamp to compress the mid-shaft

• Common target outcome of 50%occlusion of the urethra

Stiffness [kPa]Clamp geometry

25, 50, 100Flat

25, 50, 100Angled

25, 50, 100Contoured

NoneCuff-type

50,100Contoured with

knob

50Tilt 5˚

Prescribed displacements

Results

[kPa]

Effective Stress Distributions

Contoured Clamp

Cuff-Type Clamp Contoured with Knob

Female devices

PresenterPresentation NotesDuring this time we didn’t do a trial of female devices. Every now and then we would be approached to consider doing trials of some kind of device for women – but usually these failed at the first hurdle. Sometimes these would be things to put in the vagina and press on the urethra to stop urine coming out – and sometimes they would be to collect urine. There was often a problem with the critical question of whether any non-incontinent women (wives, girlfriends) of these groups of men had given them a go- had a wee in it. – and the answer would inevitably be no- there is sometimes a problem in recognising that people with incontinence are just the same as you and I but with an bladder problem – and if no-ones wives or girlfriends would dream of using such a thing then probably patients won’t either.

http://images.google.co.uk/imgres?imgurl=http://www.quintet.no/files/femassist.jpg&imgrefurl=http://www.quintet.no/nyhetsbrev.asp?do=vis&dokid=39&h=451&w=635&sz=104&hl=en&start=1&tbnid=PZhMAw9E_T6A4M:&tbnh=97&tbnw=137&prev=/images?q=femassist&svnum=10&hl=en&lr=&sa=Nhttp://images.google.co.uk/imgres?imgurl=http://www.quintet.no/files/femassist.jpg&imgrefurl=http://www.quintet.no/nyhetsbrev.asp?do=vis&dokid=39&h=451&w=635&sz=104&hl=en&start=1&tbnid=PZhMAw9E_T6A4M:&tbnh=97&tbnw=137&prev=/images?q=femassist&svnum=10&hl=en&lr=&sa=N

Female urinals

Urethral catheters

Faecal collectors

Skin damage associated with incontinence devices

Mandy FaderProfessor or Continence Technology

Faculty of Health SciencesUniversity of Southampton

UK

Medical Devices and Skin vulnerability sandpit

Slide Number 1Slide Number 2Slide Number 3Slide Number 4Slide Number 5Slide Number 6Slide Number 7Slide Number 8Slide Number 9Slide Number 10Slide Number 11SheathBody-worn urinalsDevice briefsPenile compression devices (clamp)�Design differences� �for key performance characteristicsMeasuring skin damage from clampsSlide Number 18Slide Number 19Slide Number 20Female urinalsUrethral cathetersFaecal collectorsSlide Number 24