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Use of wound dressings withsoft silicone adhesive technologyIn a multi-centre, observational study, Clare Morris and colleagues

evaluated the effectiveness of the Mepilex" Border Lite dressing

Abstract

Aim: To evaluate how pain, during and in-between dressing changes,

is affected by the introduction of Mepilex® Border Lite, a wound

dressing manufactured by Mölnlycke Health Care using Safetac®

soft silicone adhesive technology, to the treatment of different types

of paediatric wounds/skin injuries.

Methods: Wounds/skin injuries that met the criteria for inclusion in the

study were dressed with Mepiiex® Border Lite, Patients were followed

for six weeks or until their wounds/skin injuries had healed, whichever

occurred earlier. At each dressing change, pain severity before and

during dressing removal was rated by the patient and the investigator

on a scale from zero (no pain at ail) to ten (worst pain ever). Other

variables measured included: signs of trauma to wound/skin injury

and surrounding skin, the proportion of viable/non-viable tissue,

the quantity and appearance of exúdate, odour, and clinical signs

of infection. At the final dressing change, patients and investigators

completed questionnaires to rate the dressing perfonnance.

Results: Mean pain severity scores were significantly lower (p <

0.003) at the first dressing change than at baseline. Over 99.5

per cent of the Mepilex® Border Ute dressing changes were

reported to be atraumatic and more than half of the wounds

heaied within the study period, Oonformability, ease of use, ease

of removal, patient comfort, and overall experience with the

dressing were rated as 'good' to 'very good' at the vast majority of

final visit evaluations.

Conclusions: This study provides further evidence of the ability

of dressings with Safetac soft silicone adhesive technology

to minimise trauma and pain and demonstrates the ability

of Mepilex® Border Lite to overcome the clinical challenges

associated with the use of dressings on the wounds/skin injuries of

paediatric patients.

Keywords Wounds, dressings, children: accidents

CHILDREN ARE frequently exposed to physicaltrauma which ma\ result in external or inrcmalwounding. There are a number of clinical challenge.sin relation to wound management in children. Firstis the pain suffered by patients, either in relationto the wounds themselves, underKing pathologies,or as a result of trauma caused by therapeuticinterventions such as dressing-related procedures.Pain can lead to stress, the psychological aspectsof which are just as important to manage as thepain itself. Pain4nduced stress can dela> woundhealing and adversely affect patients' quality oflife (Soon and Acton 2006). It has been shown thatpatients experience most pain at dressing changes(HoIIinworth and Collier 2000).

,Although analgesia and anaesthesia can beused to help reduce pain during dressing changes,these can be expensive for healthcare providersand carers, and some analgesic and anaesthetic

agents are associated with undesirable sideeffet ts (Soon and ,^cton 200(i). Second, due tothe small size of paediatric wounds and (hedifficulties associated with dressing unusuallyshaped wounds in awkward locations, such aswounds resulting from digit and limb injuries,clinicians need access to highly flexible andconformable dressings.

In addition to managing wound pain andovercoming the difficulties posed by the size andlocation of wounds, clinicians must also deal withthe normal challenges of tissue viability, suchas effectively controlling exúdate, preventingthe ingression of foreign bodies {dirt, bacteria),and negating malodour, in a wide variety ofwound types. The dressings they select must beappropriate for these multiple purposes.

According to a World Union ol' Wound HealingSocieties (2004), the following dressing parameters

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should be considered to help minimise traumaand pain during dressing-related procedures:maintenance of moist wound healing, fluidhandling capacity, atraumatic to the wound andskin, and low allergy^ potential.

Mepilex** Border Lite is a thin, absorbent,self-adhesive island dressing with a perforatedsoft silicone adhesive (Safetac®) wound contactlayer that adheres readily to intact dry skin butdoes not stick to the surface of a moist woundand does not cause damage cm removal {White2005). The absorbent core of the dressingconsists of two layers. The first layer, a thinsheet of polyurethane foam, transports exúdateaway from the wound to the second layer,a piece of non-woven fabric, which spreadsthe exúdate horizontally. The dressing alsopossesses a vapour permeable backing filmthrough which the exúdate evaporates fromthe wound pad. The fluid handling system ofMepilex* Border Lite, in addition to its softsilicone adhesion layer inhibiting the lateralmo\ ement of exúdate from the wound to thesurrounding skin, helps to minimise the riskof maceration (Thomas 2003).

Mepilex'' Border Lite has been designed forsituations where clinicians require a thin andhighly conformable dressing for anatomical orpractical purposes, and where fluid handlingrequirements are low, that is low exuding woundssuch as leg and loot ulcers, pressure ulcers andtraumatic wuunds such as blisters and skin tears.It is available in five sizes, of which the smallerones are particularly suitable for the size andlocation of wounds in children.

A multi-centre, observational study wasundertaken to evaluate the use of Mepilex* BorderLito on different types of paediatric wounds/skininjuries such as bums, traumatic wounds (cuts,scrapes, skin tears, abrasions, finger/toe injuries,and blisters), and surgical wounds.

AimsThe primary objective of the study was to e\aluateliow pain is affected during and in-between dressingchanges by the introduction of soft siliconedressings to the treatment of different types ofwounds/skin injuries in children. The secondaryobjectives of the evaluation were to assess:

Levels of trauma.The healing of wounds/skin injuries.T he condition of the surrounding skin.1 he performance of the dressing in terms ofexúdate handling, cotiformahility, ease of use, easeof removal and patient comfort.

Wound demographics at baseline (n=36)

Wound type Bum (n-10)Surgical ( n ^ l l )Traumatic (n=13)Other* (n=2)

Wound duration (mean [mini-maxD 8.9 (1-60) days

Proportion of viable tissue (mean [mini-max]) 89.5 (30-100) per cent

*Cannula insertion site (n=l); skin /es/on post-herpes zoster (n=l)

MethodsThis multi-centre, obsenational study includedinpatients and outpatients. Inclusion criteria werethat the patients were < 16 years, had woundsand/or skin injuries that were deemed suitableto be dressed with Mepilex* Border Lite and forwhom informed consent was given. Those patientsfor whom following the protocol would be difficult,or who had a kno\\Ti allergy or hypersensitivityto any of the dressing components, or had severeunderlying disease that may have interfered withtreatment were excluded.

AssessmentAt the first consultation, baseline demographic data(age, gender, medical history) and history of thewound/skin injury were recorded. Any previouslyapplied dressings were removed and details ofthe name and ty pe of the dressings were recorded(Table 1).

The following parameters were measuredat the baseline visit and at all subsequentdressing changes:

Pain severity before dressing change.Pain severity during dressing change.Clinical signs of trauma to wound/skin injuryand surrounding skin.Condition of the surrounding skin.Percentage of viable/non-viable tissue(qualitative visual assessment).Exúdate amount (recorded usinji the standardterms of 'none', 'low', 'moderate' or 'high')/nature (recorded as 'clear (serous)', 'yellow/green', 'brown/blood' or 'other'.

I I Presence of malodour.Clinical signs of infection.nebridement (whether or not performed).Patient subjective symptoms.

Rating pain severityPain severity, before and during dressing change.was rated by the patient and the investigator on ascale from zero (no pain at all) to ten (worst painever). To facilitate this, a pain assessment tool,based on the Visual Analogue Scale (VAS) and the

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of patients demonstrating

first dressing change

han

Change in painseverity score

Prior to dressing

changeAt dressing change

(patient assessment)At dressing change

(investigator

assessment)

Decrease

No change

Increase

16

16

1

19

13

1

18

13

2

Wong-Baker Faces Scale, was used (Harms-Ringdahlcf al 1980; Keck et al 19f)ü). If the investigator feltthat this pain assessment tool was not appropriatefor use with a particular patient, for example ifthe patient was unable to verbalise the presenceor severit> of pain), then the> used the Faces,Legs, Activity, Cry and Consolabilit> (FLACOBehavioural Pain Assessment Scale for quantifyingpain beha\iours (Merkel et al 1997).

Photographs of the wounds/skin injuries weretaken to monitor their size and condition. Atthe final dressing change, the patients and theinvestigators compleled simple questionnaires torate the dressing in terms of contormability, easeof use, ease of removal, and comfort.

Dressing regimenThe investigators selected the most appropriatesize of Mepilex* Border Lite (chosen from oneof the five different sizes available) and appliedit to Ihe wound/skin injury. Combining thisdressing with other dressings was acceptableif, in the opinion of the investigators, there wasclinical Justification to do so. Investigators wereallowed to cut the borders of the dressings if itwas felt that this would facilitate application totlexion points. Dressing changes were performedwhen Judged necessary' by the investigators atfrequencies that they felt were compatible withgood exúdate management.

Each patient was fotlowed for six weeks oruntil the woimd/skin injury had healed, whicheveroccurred earlier. At any point during the study,the investigators had the option of discontinuingtreatment with Mepilex* Border Ute if, in theiropinion, the dressing was no longer appropriatefor a particular patient. Any untoward and/orunintended response that was possibly orprobably related to the dressing were recordedon the case study form.

Literature searchElectronic searches of bibliographic databases(MEDLINE, National Library of Medicine,Bethesda, USA; EMBASE, Else\ier BV, Amsterdam,

Netherlands) and internet sites (Cochrane Library,World Wide Wounds) were supplemented withmanual searches of Journals of relevance to woundmanagement to identify articles, published upto and including 2007, that describe evaluationsof dressings and pain-reheving strategies onpaediatric patients in which pain severity scoreswere recorded. Relevant studies are included inthe Discussion section below.

Statistical analysisDescriptive statistics (mean and standard deviations)were applied to the primary and secondary objectiveswhen quantitative data were established. A test wasused to analyse the pain severity scores measuredat baseline \ ersus those recorded at the subsequentdressing change (first visit).

ResultsThirty sL\ patients (boys, n=23; girls, n=i:i)with a mean age of 7.6 years (range nine days -I 5 years) with a \ariety of wound typessatisfied the criteria for inclusion in Ihe sludy.Table 1 summarises the wound demographicsat the baseline assessment. Various wounddressings were removed at baseline, for example,absorbent cellulose, hydrocolloid, honey gel, filmand foam. During the study, one patient died (thecause of death was not related to the dressing),one patient was withdrawn (he was unable toattend the clinic for follow-up dressing changes) andfive patients were withdrawTi as a result of theinvestigators deciding to switch to alternativedressings that they believed to be more appropriate.The data relating to the patients who did notcomplete the study were, however, included inthe final analysis.

Pain: The pain severity scores reported at thebaseline visit were statistically significantly higherthan those recorded at the first visit, that is,the first dressing change with Mepiiex* BorderLite. Mean score prior to dressing changewas 2.SH at baseline and 0.88 at the first visit(p = ().()()05); mean score at dressing removal(patient evaluation) was ;i.84 at baseline and1.34 at the first visit (p = 0.0002); mean score atdressing removal (investigator evaluation) was 2.5at baseline and 135 at the first visit (p = O.OOii)(Figure 1). The numbers of patients demonstratingdecreases, increases and no changes in painseverity' from baseline to first visit are presentedin Table 2. .Analgesia use at initial dressing changewas only required for two (6 per cent) patients.Of a total of 194 dressing changes involving

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Mepilex® Border Lile, analgesia was only used atiive Ci per cent) of them.

Trauma: üf the 194 dressing changes involvingMepilex® Border Lite that were evaluated, 193(99.5 per cent) were reported to be atraumatie.

Wound healing: Within the stud> period, ^0(56 per cent) wounds healed completely (mean14.5 days, range four to 42 days). In terms ofthe ratio of viable tissue (healthy granulation/re-epithelialisalion) tissue to non-\iable(sloughy/necrotic). wounds e>diibited astatistically significant larger proportion ofviable tissue at the final \1sit (mean 99.5 per cent,SD 1.9) than at baseline (mean 91 per cent.SD 17.8) (p = 0.01).

Exúdate management: The wounds treated withMepilex* Border Lite were typically associated withlow-to-moderate levels of clear (serous), yellow/green or brown/blood coloured. There were noreports of leakage. Malodour was reported at twoof the dressinjj changes.

Peri-wound skin: The proportion of patientsexhibiting healthy/intact skin around their woundsincreased from 75 per cent at baseline to92 per cent at the final visit.

Adverse reactions: Two adverse events werereported during the stud>. neither ol' which wasconsidered by the investigators as being likelyto have been related to the use of the dressing.One patient developed an eczematous rash(ihe patient concerned has a long history ofeczema-related problems). Another patientexperienced an aller}iic-t>pe reaction.

Overall evaluations (final visit)hi terms of the overall pain that was experiencedduring the use of Mepilex® Border Lite, thepatients themselves recorded mean pain severityscores of 0.2.3 prior to dressing change and 0.80at dressing change. Patients gave a mean ratingof 8.!iS out of ten for the overall performance ofthe dressing.

A summary of the investigators' final visite\aluations are presented in Figure 2. At the finalvisit, the investigators were asked to identif>which dressing they would choose if the\ couldrepeat the evaluation on each of their patients.Mepilex* Border Lite was chosen as the idealdressing for 80 per cent of the wounds andother types of dressings with soft silicone

Pain severity scores reported at the baseline

visit were significantly higher than those

recorded at the first visit

adhesive teclinolog)" were chosen lor a further9 per cent of the wounds.

DiscussionThe primary' objective of this stud> was toevaluate how pain, during and in-betweendressing changes of paediatric wounds/skininjuries, is affected by the introduction ofMepilex* Border Lite. These results demonstratethat this dressing can significant^ reduce painseverity* both before and during dressing change.

The literature review identified six articlesrelated to children which incorporate painseverity scores (based on VAS or equivalents)relating to the use of other dressings andpain-relieving strategies: Platt et al (1996),Gotschali et al (1998), Letouze ef al (2004),

Mean pain severity scores prior to and at first visitïrst dressing change with Mepilex® Border Lit

<

o

3.0

2.5

2.0

1.5

1.0

0.5

Baseline

First visit

.1V

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Investigators' evaluations at final wisi

100

80

resp

on

'S

'cen

tage

tu

a.

60

40

20

Very good

Good

Bad

Borland etaH2mS), Cassidy et«/(200^), VanTvvillert t?f tî/(2007). The low pain se\erity scoresassociated with Mepilex® Border Lite comparefavour£\bly to those reported for a number ofother dressing types and pain-relieving strategies,even though analgesia usage appears to have beentar greater in some of the published .studies. Forexamplf, in Letouze et aT^ (2005) study involving100 patients with a variety of wounds (acute,chronic and burns) treated with a lipidocolloiddressing, it was reported that analgesia wasadministered at 21 per cent of dressing changes,whereas in this stud> analgesia was used at onl>3 per cent of dressing changes. Therefore, as wellas reducing pain severity before and duringdressing change, the use of Mepilex* Border Litema> be associated with a need for less analgesiaduring changes.

The most likely explanation for the reductionin pain severity scores reported after theintroduction of Mepilex^ Border Lite is thefact that dressings with soft silicone adhesive

Conformability, ease of use, ease of removal,

patient comfort and overall experience with

the dressing were rated 'good' to 'very good'

technology are associated with atraumaticdressing changes and can be easily removedwithout causing trauma to wounds or surroundingskin (White 2005).

.-Xs healing progresses, wound exúdate levelsdecrease, thereby reducing the propensity fortrauma to peri-wound skin. A significant factorin managing this process is the selection oldressings that provide the optimum environmentin which wounds can progress to healing andeffecti\ei> manage wound fluid. Thus, thedressing selection needs to be based on thecondition of the wound and pcri-wound skin andshould be adjusted to accommodate changesin these parameters. In addition to patientsexperiencing atraumatic dressing changes andminimal pain before and during dressingremoval, their wounds demonstrated goodprogression to healing during treatment withMepilex* Border LUe.

Conformability, ease of use, ease of removal,patient comfort and overall experience with thedressing were rated 'good' to 'very good' by thevast majorit> of the investigators' at final visitevaluations. Investigators commented mainly- onthe physical handling of the dressing with regardsto it staying in place. They were generally positiveabout the flexibility and conformability of thedressing when applied to wounds that were smalland in awkward positions, such as the fingersand toes of small children. Figure ;í shows thedressing on an amputation wound on the filthdigit demonstrating excellent conformability andflexibility. Comments also indicated that dressingswere easy to appl> and remove.

A significant clinical challenge with smallchildren is keeping the dressing in place and ¡nman> cases additional fixation was required lordressing retention. The reasons given lor thelack of adhesion in this stud> included: patientsinterfering with their dressings, patients' activelifestyles exacerbating adhesion problems.and positions of the wounds making dressingadherence to skin problematic. These are issuescommonly encountered in dressing wounds inchildren. Some investigators also indicated thatthe dressing could be maintained in place forseveral days, providing good protection againstforeign material ingress.

Positive feedback from the patients and/or their parents was also much in evidence inthe case study forms. The patients gave a meanrating of 8.38 out of ten for the dressing's overallperformance. Th^esponse was ospeciall>po.sitlve \^\\ rq^BfiJktcmfcrt. flexibility and

April 2009

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nger amputation wound dressed wï

Mepilexí«) Border Lite 1

ease of use. Ihcre were a number of reports ofreduced distress and anxiet>, together with areduced need for analgesia, after the introductionof Mepilex* Border Lite. One significant commentwas from a parent who indicated that, duringtreatment with Mepilex'̂ Border Lite, the heartmonitor to which her infant was connected didnot show the increased heart rates that had beenobserved during the application and removal ofother dressings.

Methodological considerationsTrauma and pain associated with the removal ofwound dressings is of major concern to patientsand healthcare professionals. Furthermore, thetrauma to the wound bed and surrounding skin

that can occur with excessive dressing adhesionprolongs the duration of wounds, resulting inincreased treatment costs and morbidity.Not surprisingly, many clinicians invohed inthe field of wound care are becomingincreasingl>' reluctant to prescribe traditionaladhesive dressings.

These issues were carefully considered indesigning the study protocol. While recognisingthe importance of comparator groups in clinicalevaluations, it was felt that, for this particularstudy, there was no obvious candidate to evaluatealongside Mepilex* Border Lite and to have useda traditional adhesive wound dressing withthe potential to cause trauma and pain wouldha\e been unethical, particularly in view of thestud> population.

The size of the sample {36 participants) wasdeemed to be in line with other studies thathave evaluated dressings and interventions inpaediatric wound management.

ConclusionThis study was undertaken to evaluate theimpact of introducing Mepilex"' Border Lite intothe treatment regimen of children and youngpeople with a variety of wound types. The resultsshow that this product addresses the majorchallenges that clinicians face when treating suchwounds, that is, the need to use dressings thatare atraumatic and minimise pain on removal,and that have sufficient flexihiiity andconformabihty to sta> in place when applied tosmall wounds in awkward locations. Moreover,Mepilex'̂ Border Lite has been shown to becapable of promoting a wound healingenvironment that is conducive to healing,managing low-to-moderate levels of exúdate, andpreventing maceration of peri-wound skin.

This article has been

subject to open-peer

review

Clare Morris is tissueviability adviser at NorthEast Wales NHS Trust,Wrexham

Paulene Emsley is a tissueviability nurse specialist atthe Royal Hospital for SickChildren, Edinburgh

Elizabeth Marland is achildren's community nurseat Trafford n HealthcareNHS Trust, Manchester

Frans Meuteneire is anadvanced nurse practitionerat the Wound Care Centre,Zottegem, Belgium

Richard White is seniorresearch fellow at GrampianNHS Acute Trust, Aberdeen

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Worid Union of Wound Healing Societies(2004) Principles ol best pratlinvMinimising pain at wound dressing-relatedprocedures. A consensus doi ument.Available online al; www.wuwhs.org/datas/J_l/2/A_consensus,document- _Minimisms_pain_at_wouiid..dressini;_related.proiedures.pdf iLasl accessed:February 2G 2009,)

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