The cost-effectiveness of a novel soluble beta-glucan gel.

OBJECTIVE: Wounds that have stalled healing are costly in terms of patient morbidity and increase in use of material and financial resources. A natural polymer beta-glucans has been incorporated into a methylcellulose gel to provide a topical gel designed to accelerate healing in wounds where it has stalled. Although the gel provides an environment conducive to moist wound healing the active agent, beta-glucans, activate the innate immune response. METHOD: Using a Markov cohort simulation model, data were extrapolated from a double-blind randomised trial to evaluate the economic benefits of the soluble beta-glucan (SBG) gel in the treatment of diabetic foot ulcers (DFUs). RESULTS: Over an annual budget cycle, SBG gel is expected to heal 94% of wounds compared with 78% when given standard care. It also healed wounds more quickly, with the average expected healed weeks 34.4 in the SBG gel group, compared with 24.7 methylcellulose dressing group. In our model this leads to a cost saving over an annual budget cycle of £503 per patient. Note: healed weeks refers to the number of weeks when the wound has healed during the 12-week period and should not be confused with weeks to healing. CONCLUSION: The shorter healing time associated with the SBG gel treatment leads to a cost saving because fewer weeks of treatment are required to heal the wound, suggesting this is a promising new cost-effective option for the treatment of DFUs.

Clinical evaluation of a bioactive beta-glucan gel in the treatment of 'hard-to-heal' wounds.

OBJECTIVE: The aim of this evaluation is to assess the effects of a wound healing gel in a wounds of different aetiologies. METHOD: Data was recorded on the wound surface area, tissue type, and patient level of wound pain at baseline (0) and at weeks 1, 2, 3, 4, and 8. RESULTS: Of the total 39 patients enrolled in the study, 26 patients who complied with the protocol criteria completed the minimum four-week study period. During the 12-week evaluation period, seven of the 26 wounds fully healed and an additional eight wounds showed a reduction in size of more than 50 %. Of the remaining 11, five wounds showed moderate healing progression and six wounds did not respond to treatment. Following the 12 week evaluation time point clinicians reported that a further three wounds healed-a 38 % healing rate. CONCLUSION: The results give promise that this advanced gel, containing a macrophage activating substance, can be a tool in re-activating healing in stalled wounds where standard of care is no longer giving the desired healing progression.

Evaluating a native collagen matrix dressing in the treatment of chronic wounds of different aetiologies: a case series.

OBJECTIVE: To collate clinical evidence on the use of a native collagen matrix dressing, consisting of a fibrillary collagen network, in patients with a variety of chronic wounds. METHOD: Patients whose wounds had not improved in the eight weeks before the beginning of the evalutaion were recruited. All participants had their dressings changed twice weekly and received standard adjunctive wound care as part of their treatment. Data, collected over a 4-week period, included: patient demographics, wound surface area measurements, Bates-Jensen score, level of wound pain, wound infection status, wound bed preparation staging score, depth of wound according to tissue type, and photographic imaging of patients' wounds. RESULTS: We recruited 19 patients with 20 wounds and a mean wound duration of 66.6 months (range: 4-480 months). There was a mean decrease in wound surface area of 29% (median reduction: 47%). A reduction in the Bates-Jensen score was demonstrated in 85% of cases. Wound pain reduced by 66.66% and the wound bed preparation score reduced in 16 wounds with four remaining static. No adverse events arose. CONCLUSION: This case series provides clinical evidence on the use of a native collagen matrix dressing in the management of hard-to-heal wounds that have previously received local standard therapy. The decrease in wound surface area together with other data indicating improved wound status suggests that a native collagen matrix dressing supports healing and improves quality of life through reduction in wound pain.

Recommendations for the management of biofilm: a consensus document.

The potential impact of biofilm on healing in acute and chronic wounds is one of the most controversial current issues in wound care. A significant amount of laboratory-based research has been carried out on this topic, however, in 2013 the European Wound Management Association (EWMA) pointed out the lack of guidance for managing biofilms in clinical practice and solicited the need for guidelines and further clinical research. In response to this challenge, the Italian Nursing Wound Healing Society (AISLeC) initiated a project which aimed to achieve consensus among a multidisciplinary and multiprofessional international panel of experts to identify what could be considered part of 'good clinical practice' with respect to the recognition and management of biofilms in acute and chronic wounds. The group followed a systematic approach, developed by the GRADE working group, to define relevant questions and clinical recommendations raised in clinical practice. An independent librarian retrieved and screened approximately 2000 pertinent published papers to produce tables of levels of evidence. After a smaller focus group had a multistep structured discussion, and a formal voting process had been completed, ten therapeutic interventions were identified as being strongly recommendable for clinical practice, while another four recommendations were graded as being 'weak'. The panel subsequently formulated a preliminary statement (although with a weak grade of agreement): 'provided that other causes that prevent optimal wound healing have been ruled out, chronic wounds are chronically infected'. All members of the panel agreed that there is a paucity of reliable, well-conducted clinical trials which have produced clear evidence related to the effects of biofilm presence. In the meantime it was agreed that expert-based guidelines were needed to be developed for the recognition and management of biofilms in wounds and for the best design of future clinical trials. This is a fundamental and urgent task for both laboratory-based scientists and clinicians.

The importance of hydration in wound healing: reinvigorating the clinical perspective.

Balancing skin hydration levels is important as any disruption in skin integrity will result in disturbance of the dermal water balance. The discovery that a moist environment actively supports the healing response when compared with a dry environment highlights the importance of water and good hydration levels for optimal healing. The benefits of 'wet' or 'hyper-hydrated' wound healing appear similar to those offered by moist over a dry environment. This suggests that the presence of free water may not be detrimental to healing, but any adverse effects of wound fluid on tissues is more likely related to the biological components contained within chronic wound exudate, for example elevated protease levels. Appropriate dressings applied to wounds must not only be able to absorb the exudate, but also retain this excess fluid together with its protease solutes, while concurrently preventing desiccation. This is particularly important in the case of chronic wounds where peri-wound skin barrier properties are compromised and there is increased permeation across the injured skin. This review discusses the importance of appropriate levels of hydration in skin, with a particular focus on the need for optimal hydration levels for effective healing. Declaration of interest: This paper was supported by Paul Hartmann Ltd. The authors have provided consultative services to Paul Hartmann Ltd.

A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

OBJECTIVE: This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. METHOD: This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. RESULTS: We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. CONCLUSION: SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. DECLARATION OF INTEREST: Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a consultant to Matoke Holdings.

Wound healing and hyper-hydration: a counterintuitive model.

Winter's seminal work in the 1960s relating to providing an optimal level of moisture to aid wound healing (granulation and re-epithelialisation) has been the single most effective advance in wound care over many decades. As such the development of advanced wound dressings that manage the fluidic wound environment have provided significant benefits in terms of healing to both patient and clinician. Although moist wound healing provides the guiding management principle, confusion may arise between what is deemed to be an adequate level of tissue hydration and the risk of developing maceration. In addition, the counter-intuitive model 'hyper-hydration' of tissue appears to frustrate the moist wound healing approach and advocate a course of intervention whereby tissue is hydrated beyond what is a normally acceptable therapeutic level. This paper discusses tissue hydration, the cause and effect of maceration and distinguishes these from hyper-hydration of tissue. The rationale is to provide the clinician with a knowledge base that allows optimisation of treatment and outcomes and explains the reasoning behind wound healing using hyper-hydration. Declaration of interest: K. Cutting is a Clinical Research Consultant to the medical device and biotechnology industry. M. Rippon is Visiting Clinical Research Fellow, University of Huddersfield and K. Ousey provides consultancy for a range of companies through the University of Huddersfield including consultancy services for Paul Hartmann Ltd on HydroTherapy products.

Expected outcomes from topical haemoglobin spray in non-healing and worsening venous leg ulcers.

OBJECTIVE: To evaluate the effect of topical haemoglobin spray on treatment response and wound-closure rates in patients with chronic venous leg ulcers. METHOD: A linear regression model was used to forecast healing outcomes over a 12-month period. Simulated data were taken from normal distributions based on post-hoc analysis of a 72-patient study in non-healing and worsening wounds (36 patients receiving standard care and 36 receiving standard care plus topical haemoglobin spray). Using a simulated 25,000 'patients' from each group, the proportion of wound closure over time was projected. RESULTS: Simulation results predicted a 55% wound closure rate at six months in the haemoglobin group, compared with 4% in the standard care group. Over a 12-month simulation period, a 43% overall reduction in wound burden was predicted. With the haemoglobin spray, 85% of wounds were expected to heal in 12 months, compared with 13% in the standard care group. CONCLUSION: Topical haemoglobin spray promises a more effective treatment for chronic venous leg ulcers than standard care alone in wounds that are non-healing or worsening. Further research is required to validate these predictions and to identify achievable outcomes in other chronic wound types.

Influence of superabsorbent dressings on non-healing ulcers: a multicentre case series from the Netherlands and the UK.

OBJECTIVE: To record and assess the application and the progression of wound healing in patients who received Sorbion sachet S or Sorbion Sana wound dressings. METHOD: A convenience sample of patients with chronic wounds was recruited from nursing homes or community wound clinics in the Netherlands and the UK. Wound surface area measurements, pain assessment using a visual analogue scale score, patient affect (mood) and social interaction were recorded using a specifically designed evaluation template. RESULTS: Pressure ulcer (PU) (n=11) and leg ulcer (LU) (n=20) patients had a mean age of 64.6 years and 71.7 years, respectively. Mean PU surface area decreased from 15.27 cm² in week 0 to 7.63 cm² in week 8, while mean LU surface area decreased from 19.43 cm² in week 0 to 7.19 cm² in week 8. Mean PU pain decreased from 3.69 in week 0 to 0.67 in week 8, while pain at dressing change decreased from 3.23 in week 0 to 0.75 in week 8. Furthermore, mean LU pain decreased from 3.45 in week 0 to 1.90 in week 8, and pain at dressing change decreased from 3.4 in week 0 to 1.3 in week 8. The number of patients experiencing a negative influence of the PU on affect reduced from 6 in week 0 to 2 in week 8 and on social interaction from 6 in week 0 to 2 in week 8. The number of patients experiencing a negative influence of their LU on affect reduced from 7 in week 0 to zero in week 8 and on social interaction from 7 in week 0 to 2 in week 8. CONCLUSION: This case series records the response of patients' chronic wounds in terms of wound progress, patient pain and additional psycho-social factors following the application of the superabsorbent dressings and indicates that the dressings have a positive role to play in creating an environment conductive to the promotion of healing in LUs and PUs.

NPWT or HRT-dressing? Results of an expert panel and a Delphi panel analysis.

OBJECTIVE: To investigate the similarities and differences between Hydration Response Technology (HRT) and negative pressure wound therapy (NPWT) with regard to wound bed preparation, and to devise a set of recommendations for their use on the basis of the opinion of two panels. METHOD: An expert panel that analysed in vitro and clinical data as well as the similarities and differences between the two modalities was established. This culminated in a series of recommendations on which modality to use for which indication. These recommendations were presented to a Delphi panel, consisting of users of both NPWT and HRT-dressing. The panel was then asked to produce its own recommendations. RESULTS: The outcomes and recommendations of both panels were reported. NPWT is the preferred treatment modality for abdominal dehisced wounds, and to a lesser extent, for surgical wound healing by secondary intention. For all other indications, the treatment modalities are at least equal, with HRT-dressing often being the superior mode to treat wounds such as venous leg ulcers, arterial ulcers and vasculitis. CONCLUSION: In the opinion of the expert panel and the Delphi panel, both modalities share a number of clinical and non-clinical properties. However, because of the numerous advantages of HRT technology, HRT dressing has the potential to replace NPWT in a number of indications, where the patient, health-care providers and institutions may benefit. DECLARATION OF INTEREST: This study was sponsored by Sorbion GmbH & Co, Senden, Germany. Authors M. Hermans and K. Cutting are consultants to Sorbion GmbH & Co, Senden, Germany.

Is it time to re-appraise the role of compression in non-healing venous leg ulcers?

OBJECTIVE: To evaluate the role of compression in non-healing venous leg ulcers (VLUs) of > 3 months' duration. METHOD: Patients' records from three independent data sets of non-healing VLUs of > 3 months'duration were re-analysed.Two data sets were separate audits of clinical practice and the third comprised patients' records from a randomised controlled trial. Some patients in each data set were never treated with compression. The effect of compression on healing at 6 months was tested with logistic regression. RESULTS: In each data set, patients in the compression and no-compression groups were matched according to ulcer size and duration; there were no differences in comorbidities. Comparing the no-compression with the compression groups, the healing rate at 6 months was 68% vs 48% in study 1, 12% vs 6% in study 2, and 26% vs 11% in study 3. Use of compression was found to be an independent predictor of not healing with an odds ratio of 0.422, 0.456 and 0.408 in studies 1, 2 and 3 respectively. CONCLUSION: The healing rate of non-healing VLUs of > 3 months' duration in the no-compression groups was double that of VLUs in the compression groups. These findings have the potential for treatment modification if confirmed in a prospective trial. DECLARATION OF INTEREST: There were no external sources of funding for this study. The authors have no conflicts of interest that are directly relevant to the content of this manuscript, which remains their sole responsibility.

Clinical and cost-effectiveness of absorbent dressings in the treatment of highly exuding VLUs.

OBJECTIVE: To estimate the clinical effectiveness and cost effectiveness of using a sodium carboxymethylcellulose dressing (CMC [Aquacel]) and four super absorbent dressings (DryMax Extra[DM], Flivasorb [F], Kerramax [K] and sachet S [S]) in the treatment of highly exuding chronic venous leg ulcers (VLUs) in the UK, from the perspective of the National Health Service (NHS). METHOD: A decision model was constructed depicting the patient pathways and associated management of a cohort of 439 patients with highly exuding chronic VLUs of;;: 3 months of age. The model was based on the case records of a cohort of matched patients from The Health Improvement Network (THIN)database (a nationally representative database of patients registered with general practitioners (GPs) in the UK) who were treated with one of the five dressings. The model estimated the costs and outcomes of patient management over 6 months and the relative cost-effectiveness of using each dressing. RESULTS: Patients' mean age was 73.1 years, and 46% were female. Between 39% and 56% ofVLUs healed by 6 months. CMC-treated wounds that remained unhealed increased in size by 43% over the study period, whereas unhealed wounds treated with the other dressings decreased in size by a mean 34%. Consequently, CMC was excluded from the cost-effectiveness analysis. The 6-monthly NHS cost of managing a VLU with S was £3700 per patient, which was 15-28% lower than the cost of managing patients with the other three super absorbents. Additionally, use of S improved patients' health status to a greater extent than the other three super absorbents, since S-treated patients accrued 0.3-3% more QALYs. Starting treatment with S was the preferred strategy followed by DM, K and Fin that order. CONCLUSION: Within the limitations of the data set,S affords the NHS a cost-effective treatment for managing highly exuding chronic VLUs of ≥3 months of age, compared with DM, F, K and CMC.

Wound infection, dressings and pain, is there a relationship in the chronic wound?

The focus on quality of life issues in wound care has justly taken a far greater importance. With the acceptance that pain can be a major factor to the patient, and in particular, pain at dressing change comes the opportunity for avoidance and/or reduction strategies. Whilst pain has been associated with wound infection for millennia, it is only much more recently that this has received due attention from research and clinical practice. In this study, the nature of pain, changes in pain and pain associated with infection are the focal points. A Delphi approach, now a frequently used tool in wound care research, has been used to obtain expert opinion on these aspects of management.

Wound healing through synergy of hyaluronan and an iodine complex.

Hyaluronan, a glycosaminoglycan (GAG), is a polysaccharide found in many locations in the human body, such as eye, skin and soft tissue. It is also found in other mammals and bacteria. As a component of the extracellular matrix, its role in wound repair, among others, is that of providing a temporary structure to support new tissue formation. Harnessing the therapeutic action of hyaluronan into a topical application of proven clinical benefit has proved challenging. A new development in hyaluronan technology, comprising sodium hyaluronate and iodine complex, offers a novel approach in exploiting the benefits of hyaluronan and delivering real clinical benefits for a wide range of wound types.

Managing wound exudate using a super-absorbent polymer dressing: a 53-patient clinical evaluation.

This real-life, observational evaluation shows that, by absorbing and retaining within its structure the corrosive enzymes found in chronic exudate, this dressing both reduces the likelihood of peri-wound maceration and promotes healing.