Imm REseARCH - The effect of a silver- containing Hydrofiber® dressing on superficial wound bed and bacterial balance of chronic wounds Pat Coutts, R Gary Sibbald Key Points «¢the weatment of eheenic wounds represents a major cost to society and has a prfound effect on the subject's quality of ite sive eressings may provide an alternate topical method to owl supericalbaceral buen Coutts P, Sibbald RG. The elfect of a siver-containing Hydrofiber dressing on superficial wound bed and bacterial balance of chronic wounds. Int Wound J 2008;2:348-356, ‘ABSTRACT The teatment of cronic wounds represents a major cost to society and has a profound effect on the participant's quality of life. Chronic wounds may have an increased bacterial burden that can impair healing without al the clinical signs of infection. Ser desings may provide an alternative topical method to coil bactrial burden. The primary aim of this stuty was to evaluate the clinical improvement in chronic wounds through the effec on wound size, maceration, resolution of surface slough and conversion to heathy aration during 2 4-week application ofthe siver-contairng Hysofiber® cessing, Tis was a single centre, open-label ase series study which included a total of 30 evaluable participants: fur with dlabetc neuropathic foot cers, 13 venous sass ics, four pressure uicers and ine miscelaneous wounds that cd nt fit any ofthe previous categories. Al participants had adequate vasclr suppl, indicating the potential to hea. The wounds were Stalled ot had the signs and symptoms consistent wth cial colonisation. The underjing cause ofthe ulceration wa identified and corrected, or the symptoms and signs were treated. This was followed by the apoiation of siver-containng Hyroiber® dressings for aperid of 4 weeks. The majority of wounds tested decrease in size (70%) with decreased exudate, decreased purulence and resolution of surface slough (75%). There was an inceased qualty and quantity of heathy granulation tissue. Unlc some sversrssng, the Hyerober® and siver combination dressing was unlikely to cause burning and stinging on application Perwound maceration was present in 54% of partipants at baseline, and 85% ofthese resoled with this dressing, A dsiughing action was seen in those patients with preexisting slough at baseline ad its removal wl lower the bacterial burden ofthe wound Key words: bsarpive desing @Bacteal buen « Cita cobain © Hote Age infection « Wounds INTRODUCTION The treatment of chronic wounds represents a ‘Authors Fat Coun AN, Chal and Trae Ce-rdator Tenor Wound Healing Clic. Toronto, Onan, Canada Gay Sal, MD, FRCPC MED) (Dem), Mea rlescr of Medicine and Pubic Heath Sects, Unies of Toronto, Terorte, Ontario, Canada and Director af Demtolagy Day Care and Weund Healng Circ, Women's Colege, Heath Scares Cente, Trot, Oar, Canada ‘Address for correspondence: 86 Sebo. Demsolgy Day Cae are Vioune Heng Clinic, Waren’ Coleg, Heat Seances Cente, 7, Genie set Tern.” Onan Canada, MSS 182 (© Blackwell Publishing Lt and Medialtelpines com Inc 2005 Itt major cost to society (1) and has a profound effect on the subject's quality of life (2). An approach to treatment must include correcting or optimising the symptoms and signs asso- ated with the underlying cause along with ‘moist interactive healing (8). Often, chronic wounds have an increased bacterial burden that can impair healing without all the clinical signs of infection (4,5) onal Wound Journal « Vol 2 No4Silver dressings may provide an alternative topical method to control superficial bacterial burden (6,7). This increased bacterial burden. and possible subsequent infection are both. significant issues to consider in stalled wounds (8,9). Indeed, the need for bacterial balance has become a recent “hot topic’ for persons with chronic wounds (10). Recent stu- dies have also focused on the additional anti- inflammatory action of silver and its potential to improve healing (11,12). ‘The role of Hydrofibers® in healing Absorptive fibrous dressings remain some of the most widely used products in the current treatment of wounds (13). The first absorptive products such as gauze suffered from many limitations including easily dehydrated, often painful and adherent, fibre shedding and decreased host resistance for bacterial damage (1415). The newer sophisticated gelling fibres are more appropriate for moisture and bacter- ial balance in chronic wounds (16,17). (One such product class is the Hydrofibers®, combining the benefits of both hydrocolloids and absorptive fibrous dressings. This combi- nation provides a superior clinical perfor- mance when compared with alginates alone (18). Hydrofibers® bind water internally and are not biodegradable like alginates that bind water externally (19). Hydrofibers® have a high tensile strength, even in the hydrated state, and can be easily removed atraumati- cally and intact from the wound surface (20). The benefits of Hydrofibers® have been shown in a number of clinical studies (167,20) The eect of Hydtoiber® cessing on superil wound The clinical sucess of the Hydrofiber” pro- ducts has led to the development of novel combined silver-containing Hydrofiber dres- sings (Aquacel® Ag). This dressing has a role in the management of exudate and bacterial burden in the wound environment. ‘The carboxymethyiceliulose (22) core of the Hydrofiber® dressing is designed to absorb exudate directly into its fibres, stimulating the controlled release of ionic silver to the wound (232425). Recent scanning micro- scopic studies have demonstrated in titro that Hydrofiber® dressings helped to reduce bacterial burden through bacterial sequestra- tion and retention into the dressng’s structure 26, Experimental animal models have recently been developed to evaluate antimicrobial pro- ducts (27), This model confirmed the Hydrofiber® dressing in vivo also sequesters and retains bacteria (28). Antibacterial in vitro tests in another model have confirmed the dressing ability to deal with bacteria across a broad specirum of species (29,3031), These observations have been confirmed clinically in both acute (32) and chronic wounds (33). Wound environment and wound bed reparation A recent innovation in chronic wound care is represented by the ‘Wound Bed Preparation Paradigm’ as proposed by Sibbald etal. @) (Figure 1). The cause of the wound and patient-entred concerns must be addressed prior to optimising local wound care (3) ‘There are three main elements to good wound bed preparation, namely moisture a Patent with chronic wound t — ‘Local wound Patien-cenered - Lirearcause + Venous {Arterial Surgical [ amowie 1 debridement | “tacwors a. mS “Superficial bacterial burden prolonged ‘nftanmaton + Quality of life + Adherence, coherence Moisture balance Hydrofiber? with ster 1. job with silver wound balance paradigm ladaped from Sibbald eta (3) (© Blackwell Publishing Lu and Mediaheplinescom ic 2005 @ International Wound Jounal @ Vol 2 No 4 Key Points the need for bail tance has became 2 eer Pot oe forgone th conc woe 5 abrpive fibrous tesoge tema sme ofthe mos wey ties produce in the caret treatent of wounds one such predict das i the tyes” conbring the benais of tot Pyrcalis and abt ros dest te deal sucess ote Pydoibe peis ha ed 0 eceerets at onanes shercontaining Hydrofber® ores septal Ag wound cae eee by Word Be Peaton Parad 2 pope Sle al tte case ofthe wound and patentee concen mst be atresed port opting lca wound cae| Key Points moisture tance is important for mary wound. functions incuingre-epitellsation and sepa bacterial lance is imperative in the wound envionment to nse unhindered healing 2 reser in vito desing sty emonstated a ik betwen the sequestereg of micr-agarisns and a decrease in wound cial Caloiaton the primary aim ofthis study was to evaluate cial irovement ‘essing the change in weund size, maceration, resdltion of surface ough ard. conversion to healthy granulation of 2 4 week acplcaton of the sve certating yo cessing maceration was assessed by visual examination of the su. rounding skin and the wound edges exudate was measured by ces sing saturation ard the evidence of enudste on the seconde thessng the improvement ofthe wounds was determined by 2 decrease in wound size, and surtace slough alg with an increase inthe amount of hea gnu lation tissue Te eet of Kyte desing on supe wound balance (34), decrease bacterial burden or inflammation (35) and wound debridement (6). Effective products or combinations of pro- ducts allow healing to progress at an optimal rate, for example, ifa wound is 30% smaller at ‘week d it is likely to heal by week 12 (37) Importance of moisture balance Moisture balance is important for many wound functions including re-epithelalisation and repair (35) To prevent a delay in healing, itis essential that the wound bed is neither too moist nor to0 dry (36,38). The correct choice of dressing is therefore essential. Hydrofibres have the ability to provide moisture balance through their fluid-lock action (9). The trapping of wound exudate within the Hydrofiber® structure forms a cohesive gel ‘maintaining a moist wound surface interface (22), providing the possibility of debridement through autolysis, The addition of silver to the Hydrofibee® dressings allows the release ionic silver for antibacterial activity and potential antiinflammatory action, Importance of infection control Bacterial balance is imperative in the wound environment to ensure unhindered healing. If increased bacterial burden is present, it needs to be treated, or there is a distinct risk of infection. Many antibacterial products exist, both topical and systemic (40). Topical anti microbials may have significant side-effects, including, allergies, bacterial resistance, lack Of moisture balance and tissue toxicity (41) A recent in vitro dressing study demonstrated a link between the sequestering of micro= organisms (42) and a decrease in wound critical colonisation. The silver-containing Hydrofiber” dressing provides a low controlled dose of ionic silver to destroy bacteria and encourage moist- ure balance (30), This choice provides an effec- tive and wound friendly agent to create a healing enviror-ment METHODOLOGY Study objectives The primary aim ofthis study was to evaluate clinical improvement measuring the change in wound size, maceration, resolution of surface slough and conversion to healthy granulation of a 4week application of the silver-contain- ing Hydrofiber” dressing. Maceration was assessed by visual examin- ation of the surrounding skin and the wound edges. Exudate was measured by dressing saturation and the eviclence of exudate on the secondary dressing, The improvement of the wounds was determined by a decrease ‘wound size, and surface slough along with an increase in the amount of healthy granulation tissue, Inclusion criteria General All participants were required to be between 18 and 90 years of age. The ulcer duration was ‘more than 1 month with adequate vascular supply and the ability to heal. The wounds demonstrated stalled healing (ie. if the ulcer showed less than 30% healing 1 month prior to the inclusion) or had the signs and symp- toms consistent with critical colonisation, Diabetes These participants had a vasculature suitable for healing (Le. toe pressure >50 mmHg, Ankle Brachial Index (ABI) > 0-65 or a palp- able pulse). Pressure downloading was pro- vided with a pneumatic walker or deep toed shoes with orthotic. Their haemoglobin A1C was less than 0-12, and there was no signifi- cant additional systemic disease that would impair healing. Venous stasis These participants had an ABI of >0-7 and are able to tolerate compression therapy. Pressure ulcers Participants were assessed utilising the Braden scale, and if their calculated score was <12, then these participants were required to have a therapeutic surface. Miscellaneous wounds Miscellaneous wounds must have their cor- rectable factors leading to ulceration corrected or the related signs and symptoms optimised, Exclusion criteria The study excluded any patient without the ability to heal. Additional criteria included uncontrolled cardiac failure, a haemoglobin <80 g/L and albumin <20 g/L, evidence of severe liver or kidney disease (known values © Blackwel Publishing ltd and Medicaepinescom irc 2005 @ Intemational Wound Jounal Vol 2 No 4Table 1 Patent demographics Patient profile Demographic Per cent of female 50% Age 58-25 yeas Range 18-89 yeas Mean dation of wound 30-22 months ange 2-144 months Mean sie of wound 16-70 en? Range 05-220 om? ‘Aetioiog7 Diabetic 13% Venous 23% Pressure 13% other 2% Receiving stoic antibiotics 56% greater than three times normal), Participants undergoing immunosuppressive therapy or taking systemic antibiotics at the time of entry were excluded for the study. Study groups and treatments administered Four groups of participants were studied with the silver-containing Hydrofiber® dressing for 4 weeks. Diabetic neuropathic foot ulcers were treated according to the recommendations of Browne and Sibbald (43) and Canadian Consensus Recommendations (4). For venous stasis ulcers, the protocols used are outlined by Sibbald (45) and Kunimoto (46). The approach to compression therapy was based on a meta-analysis of Fletcher et al (47) Pressure ulcer treatment was based upon the US National Pressure Ulcer Advisory Panel (48), an outline of the reviewed pressure ulcer literature (49) and Canadian Pressure Uler Consensus Recommendations (50). A group of miscellaneous ulcers were treated using var- ious treatment protocols; al aimed at treating ‘or correcting the underlying cause The characteristics of the wound base and surrounding skin were recorded at each patient visit along with wound measurements The local wound therapy inchided surgical debridement where appropriate. This was fol- lowed by applications of Hydrotiber® with sil ver dressings, twice a week, fora period of up to 4 weeks or complete healing. We monitored the effect ofthis dressing on the reduction in wound size and the signs and symptoms of © Blackwell Publishing Ld and Medicahelpies com inc 2005 @ Ins The eect of Hyhoer® dessng on superilal wound increased bacterial burden. No specific bacter- ‘ology was evaluated in this study, as this was to be the focus of a future evaluation. RESULTS, A total of 30 evaluable participants, four dia- betic neuropathic foot ulcers, 13 venous stasis, ulcers, four pressure ulcers and nine miscella- neous wounds, did not fit into any of the Previous categories, Demographic data (Table 1) Of the 30 evaluable participants, 50% were female. The participants’ mean age was 54:25 years with a range of 18-89 years. The mean ‘wound duration was 30-22 months with a range of 2-144 months, The mean wound size at baseline was 16-70 em? Efficacy evaluations (Figures 2 & 3) Seventy percent of participants demonstrated clinical improvement with a reduction in wound size from baseline (16-70 cm?) to the end of the study (12-15 cm’), representing a 27% reduction in mean wound size Individually 17 wounds became smaller, 11 showed no change and 2 became larger (Figure 3). A majority of participants had a decreased exudate and improved peri wound maceration in 75% and) frequent increased quality and quantity of granulation tissue. The dressing rarely caused buming and stinging on application (Figure 2) Safety evaluation ~ frequency and type of adverse events Adverse events were reported in three of the 30 evaluable participants (10%). These led to early withdrawals of one participant. The adverse events (none of which were classified as serious) were due to dressing slippage, local burning and stinging on application and a deep infection requiring systemic anti- biotics. There were no major safety concems reported with this product. DISCUSSION AND OVERALL CONCLUSIONS ‘The process of wound healing can be opti- mised by applying the preparing the wound bed paradigm to persons with chronic ‘wounds. The first consideration should be to correct the cause and address patient-centred ational Wound Joural @ Vol 2 No 4 Key 1 2 total of 30 evaluable pat: pants, four diabetic, 13 venus, four pressure and 9 macele neous were evlled in the study serety percent of paridgans erersvted cal -mpove © 2 maori ofpartipants had 2 creased wxate ad ironed peraound maceration on 3 adese events we rego in our 30 patie poms later the ser conaring Hy. fer desing imestoated in ths study alone the majority of paricpans wth racrtion to facitate resolsion trough absrbary and fickKey Points | a) and de wll be repr seventy percent ofthe woun stutied Rada decease in cer the 4 pat al weeks of tc atin with ric wounds that progress awards hedling had in sioupho all the signs and symptoms of increased baceral burden are needed when deep or sur ydofibe cessing Pee Static 8 Figure 2. Pat concerns, Local wound care can be facilitated through appropriate debridement combined with the need to achieve bacterial balance and moisture balance. The silver-containing, Hydrofibre dressing investigated in. this study allowed the majority of participants with maceration to facilitate through absorbency and fluid-lock mechan- isms that prevented the over hydration of the wound surface and margins. The ability to decrease slough on the surface of the wound isan indirect indication of bacterial and moist sre balance. Specific studies evaluating effect on wound bacteriology both in the superficial resolution and deep compartment will be reported at a future date. Seventy percent of the wounds studied had a decrease in size over the 4 weeks of the study Not all participants with chronic wounds healing had a decrease in slough or the improvement in all that progressed towards the signs and symptoms of increased bacterial burden. If host resistance is adequate to con: trol the bacterial insult, the wounds may have mproved through and independent anti- inflammatory action that has been alluded to in previous publications, Further studies on the potential for silver to exert an an matory effect and to assess whether this effect, can be separated from the antimicrobial action All chronic wounds contain micro-organ- jams, and the process of wound healing can ‘occur in their presence (51). Wound contam- nation is defined as the presence of non repli cating organisms within the wound, Wound colonisation also includes the presence of replicating micro-organisms attached to the © Blackwell Pulshing Ld and Meclelplines con ‘Wound maceration Improved 46s Wound slough Increased __Noslough 33 No api \ Decreased ‘wound tissue without subsequent host injury When wound organisms are in balance, healing is not impaired; however, an burden (>10° organisms Per gram tissue) may impair healing despite absence of clinical -ganism number is only part of th that results in the clinical signs and symptoms of infection. The virulence of the organism is also important with other organisms such as bacterial increased bacterial igns of infection (34,52). equation Streptococcus causing tissue damage at lower organism numbers. Host resistance, however, both locally and systemically important determinant for healing, Ifthe host is strong, healing may occur despite high organism numbers, but if the host resistance is the most is lowered, even lower numbers of organisms can significantly delay or prevent healing, ‘These concepts are represented in the equation: Infection = (Organism number > Virulence)/ Host resistance. ‘When there is an increased bacterial burden. in the local superficial compartment wound, robial agents are often used for short periods (eg, 2-6 weeks) as illustrated in antim Figure 3. Some of the clinical signs of local burden include nal or exuberant deep red friable gran- increased bacterial may abno. increased discharge, pus or odour from the wound (53). Topical wound agents should contain the same agent as systemic therapy, have a low toxicity for living tissue and low sensitisation potential (unlikely to ‘cause allergic reactions). Agents that combine antibacterial properties with moisture balance are preferred to simple crean formulations that may leave an unwanted ‘on the skin surface, or ointmentso 45 17 smaller 11 no change 2 larger 40 35 30 25 Wound size (em?) The eet of hydro dessng on supercil wound 12.3.4 5 6 7 8 9 1011 12131415 1617 18 19 2021 22.23 24 25 2627 28 29 30 Patient umber Figure 3. Changes in wound area patient by patient. NC, novel charge Systemic antimicrobial agents are needed when deep or surrounding tissue (including, underlying bone infections) are present. Deep infection may be indicated if a wound probes to bone. If the infection spreads into the sur- rounding skin, the clinical symptoms and signs of cellulitis may include increasing pain, erythema, swelling and warmth. Deep or surrounding skin infections may be asso- ciated with general malaise and_ systemic signs such as fever and leukocytosis especially when accompanied by bacteremia. The use and over use of systemic antibiotic agents has led to the evolution of multiple antibiotic-resistant bacteria such as methicil- lin-resistant , Staphylococcus aureus (MRSA), Bacterial silver resistance is governed by plas- mids that express several genes that encode proteins with several different types of activ- ities, including periplasmic silver-binding proteins, silver efflux pumps and silver sen- Sor/responder transcription inducing pro- teins. Tonic silver dressings provide an alternate method to control bacterial burden, They are effective against MRSA and other multiple antibiotic-resistant organisms (30,54), Safety and efficacy Hydrofiber” with silver dressing proved to be beneficial in the treatment of chronic wounds. ‘The dressing provided a wound environment conducive to healing, with control of bacterial burden, moisture balance and possible autolytic debridement as evidenced by the reduction in slough (55). There were no serious adverse events in the study, and only one ofthe partici- pants experienced temporary burning and stinging on application. Another patient had difficulty keeping the dressing in place prob- ably related to friction and shear associated with repositioning, in sensate pressure uleer. The third adverse event was the requirement of systemic antibiotics for surrounding skin cel- lulitis. This was most likely related to a decreased host resistance and spread of the bacteria from the surface wound compartment. Overall it could be concluded that Hydrofiber” with silver was a safe product Our health care practitioners documented that this dressing was easy to use in the clinical setting requiring less preparation time than other antibacterial agents they have pre- viously used. To increase the wear time in some © Blackwell Publishing Ltd and Medicahepines.com ie 2008 @ International Wound Journal @ Vol 2 No & Key Points Hydotbe” with sr cessing Proved to be benef inthe treatment of chronic wounds the desing provided 2 wound environment conducie to hea- ing, with contol of bacterl burden, moisture balance and pssble autoytc debridement 25 evidenced by the reducton in slough there axe no serous adverse retin the study rest wounds improved an the majority of the paripens found the desing camrable Specic benefal observations incu the lack of sigrifcant staining ofthe skin when com: aed with previous experience vith a nanocystatie her thesingKey Pr most particpans had no odou on desing removal ‘vera, both participants and tursng staf were highly satis: fed wt yor with iver skesing four initial stds proved suc cessful in chronic wounds that rete stalled of rot healing at the expected rate this ase suey wil be flowed ty a more tity contd ase series to ives he sigrical and deep compart of the wounds independent to see we cn vabdate these ical Snes the Hyotbe® wth onisds- ver isa patent endl desing that provides the three con nents of local wound care: rmosture balance, bacterial ba ance and debridement the advantages of Hyroibe”™ with sber documented in this cal case series ‘| The eet of Hote” desing on supe wound Prevent ki control MRSA Hyekofter ' with silver Superficial Fable granulation Hands (patients providers) a tds patents, pro Body ids Peer e syanie > | bay Lista ca Bateenla ne a sys mic or parent agents needed evel of invasion - “Treatment to revere haste balance Contamination ove wound and in dressing Tnfeston coir! and antibacterial coment ‘Superficial wound surface “Topical antimicrobial Deep wound compartment Systemic agens Surrounding skin Systemic infect Figure 4, Stages of chronic wound bacerial buen — infin ard teatmert wih Hydrof study subjects with high exudation, there was a need to have a highly absorbent secondary dressing. Most wounds improved, and the ‘majority of the participants found the dressing comfortable. Specific beneficial observations included the lack of significant staining of the skin when compared with previous experience with a nanocrystalline silver dressing, Most participants had no odour on dressing removal. Overall, both participants and nursing. staff were highly satisfied with Hydrofiber with silver. Indeed, it was rated as being significantly better than previous topical therapies in the participants studied. (Our initial studies proved successful in chronic wounds that were stalled or not heal- ing at the expected rate. This case survey will be followed by a more tightly controlled case series to investigate the superficial and deep compartment of the wounds independently, to see if we can validate these clinical findings. ‘eparating superficial and deep compart- ments, we may be able to develop criteria, where topical antimicrobial dressings as exem- plified by a Hydrofiber” with ionised silver {© Blackwell Publishing Ltd and Medieahepies.com Inc 2005 @ Intemational Wound loural @ Systemic or parental Parental agents (Aquacel® Ag) are the first choice, and identity those participants who require cotreatment with systemic antibiotics from the onset CONCLUSIONS ‘The Hydrofiber with ionised silver is a patient friendly dressing that provides the three components of local wound care, moist- ure balance and exudate control, control of bacterial burden in some participants along with minor autolytic debridement properties (Figure 3), ‘The advantages of Hydrofiber® with silver documented in this clinical case series were reduction in wound size (ie. healing), low incidence of burning and stinging both during, application and removal, ease of use, lack of staining, exudate management — absorb exudate and provide fluid lock that prevents maceration of surrounding skin and desloughing of devitalised tissue on the wound surface, lowering bacterial load. This study was a descriptive case series, and as such, no statistical analysis was carried out, The individual patient wound sizechanges are illustrated in Figure 3 to demon- strate that most wounds decreased in size Further studies need to be performed to See if the effects described in this report reach statistical significance. ACKNOWLEDGEMENT This study was funded by a clinical grant from ConvaTec (a Bristol-Myers Squibb Company). REFERENCES 1 Metzger S. Clinical and financial advantages of ‘moist wound management Home Healthe Nurse 20022(9;586-90, 2 Reddy M, Kohr R, Queen D, Keast D, Sibbald RG. Practical treatment of wound pain and trauma: a patient centered approach. An Overview. Ostomy Wound Manage 2003449 (4A Supp2-15. 3 Sibbald RG, Willamson D, Orsted HL, Campbell K, ‘Keast D, Krasner D, Sibbald D. Preparing the wound bed ~ debridement, hacteril balance and moisture balance. Ostomy Wound Manage 2000461): 14-22.24-830-5, 44 White RJ, Cooper B, Kingsley A. 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