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AIMS: To determine clinical outcomes and explore prognostic factors related to ulcer healing in people with a clinically infected diabetic foot ulcer. METHODS: This multicentre, prospective, observational study reviewed participants' data at 12 months after culture of a diabetic foot ulcer requiring antibiotic therapy. From participants' notes, we obtained information on the incidence of wound healing, ulcer recurrence, lower extremity amputation, lower extremity revascularization and death. We estimated the cumulative incidence of healing at 6 and 12 months, adjusted for lower extremity amputation and death using a competing risk analysis, and explored the relationship between baseline factors and healing incidence. RESULTS: In the first year after culture of the index ulcer, 45/299 participants (15.1%) had died. The ulcer had healed in 136 participants (45.5%), but recurred in 13 (9.6%). An ipsilateral lower extremity amputation was recorded in 52 (17.4%) and revascularization surgery in 18 participants (6.0%). Participants with an ulcer present for ~2 months or more had a lower incidence of healing (hazard ratio 0.55, 95% CI 0.39 to 0.77), as did those with a PEDIS (perfusion, extent, depth, infection, sensation) perfusion grade of ≥2 (hazard ratio 0.37, 95% CI 0.25 to 0.55). Participants with a single ulcer on their index foot had a higher incidence of healing than those with multiple ulcers (hazard ratio 1.90, 95% CI 1.18 to 3.06). CONCLUSIONS: Clinical outcomes at 12 months for people with an infected diabetic foot ulcer are generally poor. Our data confirm the adverse prognostic effect of limb ischaemia, longer ulcer duration and the presence of multiple ulcers.

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OBJECTIVE: To estimate the patterns of care and related resource use attributable to managing acute and chronic wounds among a catchment population of a typical clinical commissioning group (CCG)/health board and corresponding National Health Service (NHS) costs in the UK. METHOD: This was a sub-analysis of a retrospective cohort analysis of the records of 2000 patients in The Health Improvement Network (THIN) database. Patients' characteristics, wound-related health outcomes and health-care resource use were quantified for an average CCG/health board with a catchment population of 250,000 adults ≥18 years of age, and the corresponding NHS cost of patient management was estimated at 2013/2014 prices. RESULTS: An average CCG/health board was estimated to be managing 11,200 wounds in 2012/2013. Of these, 40% were considered to be acute wounds, 48% chronic and 12% lacking any specific diagnosis. The prevalence of acute, chronic and unspecified wounds was estimated to be growing at the rate of 9%, 12% and 13% per annum respectively. Our analysis indicated that the current rate of wound healing must increase by an average of at least 1% per annum across all wound types in order to slow down the increasing prevalence. Otherwise, an average CCG/health board is predicted to manage ~23,200 wounds per annum by 2019/2020 and is predicted to spend a discounted (the process of determining the present value of a payment that is to be received in the future) £50 million on managing these wounds and associated comorbidities. CONCLUSION: Real-world evidence highlights the substantial burden that acute and chronic wounds impose on an average CCG/health board. Strategies are required to improve the accuracy of diagnosis and healing rates.

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OBJECTIVE: To assess clinical outcomes and cost-effectiveness of using a two-layer cohesive compression bandage (TLCCB; Coban 2) compared with a two-layer compression system (TLCS; KTwo) and a four-layer compression system (FLCS; Profore) in treating newly-diagnosed venous leg ulcers (VLUs) in clinical practice in the UK, from the perspective of the NHS. METHOD: This was a retrospective cohort analysis of the case records of patients with newly-diagnosed VLUs randomly extracted from The Health Improvement Network (THIN) database (a nationally representative database of clinical practice among patients registered with general practitioners in the UK) who were treated with either TLCCB (n=200), TLCS (n=200) or FLCS (n=200). The clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over six months after starting treatment. RESULTS: Patients' mean age was 72 years and 58% were female. Time from wound onset to the start of compression was a mean of two months, and when starting compression the wound size was a mean of 45 cm2. The distribution of healing was significantly different between the three groups; 76% of wounds in the TLCCB group healed by six months compared with 70% and 64% in the TLCS and FLCS groups, respectively (p=0.006). Time to healing was significantly less in the TLCCB group compared with the two other groups (p=0.003). Patients in the TLCCB group experienced better health-related quality of life over six months (0.413 quality-adjusted life years (QALYs) per patient), compared with the TLCS and FLCS groups (0.404 and 0.396 QALYs per patient, respectively). The mean six-month NHS management cost was £3045, £3842 and £4480 per patient in the TLCCB, TLCS and FLCS groups, respectively. CONCLUSION: Real-world evidence demonstrates that treating newly-diagnosed VLUs with TLCCB, compared with the other two compression systems, affords a more cost-effective use of NHS-funded resources in clinical practice since it resulted in an increased healing rate, better health-related quality of life and a reduction in NHS management cost.

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OBJECTIVE: To assess clinical outcomes and cost-effectiveness of using a two-layer cohesive compression bandage (TLCCB; Coban 2) compared with a two-layer compression system (TLCS; Ktwo) and a four-layer compression system (FLCS; Profore) in treating venous leg ulcers (VLUs) in clinical practice in the UK, from the perspective of the National Health Service (NHS). METHOD: This was a retrospective analysis of the case records of VLU patients, randomly extracted from The Health Improvement Network (THIN) database (a nationally representative database of clinical practice among patients registered with general practitioners in the UK), who were treated with either TLCCB (n=250), TLCS (n=250) or FLCS (n=175). Clinical outcomes and health-care resource use (and costs) over six months after starting treatment with each compression system were estimated. Differences in outcomes and resource use between treatments were adjusted for differences in baseline covariates. RESULTS: Patients' mean age was 75 years old and 57% were female. The mean time with a VLU was 6-7 months and the mean initial wound size was 77-85 cm2. The overall VLU healing rate, irrespective of bandage type, was 44% over the six months' study period. In the TLCCB group, 51% of wounds had healed by six months compared with 40% (p=0.03) and 28% (p=0.001) in the TLCS and FLCS groups, respectively. The mean time to healing was 2.5 months. Patients in the TLCCB group experienced better health-related quality of life (HRQoL) over six months (0.374 quality-adjusted life years (QALYs) per patient), compared with the TLCS (0.368 QALYs per patient) and FLCS (0.353 QALYs per patient). The mean six-monthly NHS management cost was £2,413, £2,707 and £2,648 per patient in the TLCCB, TLCS and FLCS groups, respectively. CONCLUSION: Despite the systems studied reporting similar compression levels when tested in controlled studies, real-world evidence demonstrates that initiating treatment with TLCCB, compared with the other two compression systems, affords a more cost-effective use of NHS-funded resources in clinical practice, since it resulted in an increased healing rate, better HRQoL and a reduction in NHS management cost. The evidence also highlighted the lack of continuity between clinicians managing a wound, the inconsistent nature of the administered treatments and the lack of specialist involvement, all of which may impact on healing. DECLARATION OF INTEREST: This study was supported by an unrestricted research grant from 3M Health Care, UK. 3M Health Care had no influence on the study design, the collection, analysis, and interpretation of data, or on the writing of, and decision to submit for publication, the manuscript.

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Bullosis diabeticorum is considered a rare skin manifestation of diabetes mellitus. Tense blisters appear rapidly, mostly on the feet, the cause of which is unclear, with multiple pathophysiologies hypothesised. This is a retrospective review of 4 diabetic patients who presented over six months with diabetic bullae; the condition may therefore not be as rare as commonly believed. All the patients had early surgical debridement followed by topical negative pressure wound dressings. A multidisciplinary team that included vascular surgeons, diabetologists, diabetic foot care team, wound care team, physiotherapists and occupational therapists managed the patients and none of them required amputations. We propose an alternative way of managing these patients with early surgical debridement followed by topical negative pressure wound dressing.

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INTRODUCTION: Presacral venous bleeding is an uncommon but potentially life threatening complication of rectal surgery. During the posterior rectal dissection, it is recommended to proceed into the plane between the fascia propria of the rectum and the presacral fascia. Incorrect mobilisation of the rectum outside the Waldeyer's fascia can tear out the lower presacral venous plexus or the sacral basivertebral veins, causing what may prove to be uncontrollable bleeding. METHODS: A systematic search of the MEDLINE(®) and Embase™ databases was performed to obtain primary data published in the period between 1 January 1960 and 31 July 2013. Each article describing variables such as incidence of presacral venous bleeding, surgical approach, number of cases treated and success rate was included in the analysis. RESULTS: A number of creative solutions have been described that attempt to provide good tamponade of the presacral haemorrhage, eliminating the need for second operation. However, few cases are reported in the literature. CONCLUSIONS: As conventional haemostatic measures often fail to control this type of haemorrhage, several alternative methods to control bleeding definitively have been described. We propose a practical comprehensive classification of the available techniques for the management of presacral bleeding.

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OBJECTIVE: To evaluate the effectiveness of a telehealth system, using digital pen-and-paper technology and a modified smartphone, to remotely monitor and support the effectiveness of wound management in nursing home residents. METHOD: A randomised controlled pilot study was conducted in selected nursing homes in Bradford, which were randomised to either the control or evaluation group. All patients with a wound of any aetiology or severity, resident in the selected nursing homes were considered eligible to participate in the study. Residents in the control homes who had, or developed, a wound during the study period, continued to receive unsupported care directed by the nursing home staff (defined as 'standard care'), while those in the evaluation homes received standard care supported by input from the remote experts. RESULTS: Thirty-nine patients with a wound were identified in the 16 participating Bradford nursing homes. Analysis of individual patient management pathways suggested that the system provided improved patient outcomes and that it may offer cost savings by improving dressing product selection, decreasing inappropriate onward referral and speeding healing. Despite initial anxiety related to the technology most nursing-home staff found the system of value and many were keen to see the trial continue to form part of routine patient management. CONCLUSION: The current study supports the potential value of telemedicine in wound care and indicates the value that such a system may have to nursing-home staff and patients. DECLARATION OF INTEREST: This study was funded by a Regional Innovation Fund grant from the Yorkshire and Humberside Strategic Health Authority. The authors have no conflict of interest to declare with respect to the article or its contents.

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OBJECTIVE: To estimate the clinical and cost-effectiveness of using a skin protectant (Cavilon No Sting Barrier Film [NSBF] or Cavilon Durable Barrier Cream [DBC]; 3M) compared with not using a skin protectant in the management of venous leg ulcers (VLUs), in the UK. METHOD: A decision model was constructed depicting the patient pathways and associated management of a cohort of patients with and without a Cavilon formulation, plus dressings and compression. The model was based on the case records of a cohort of matched patients from The Health Improvement Network (THIN) database, who were first diagnosed with a VLU between 1 Jan 2008 and 31 Dec 2009. The model estimated the costs and outcomes of patient management over 6 months and the cost-effectiveness of using a Cavilon formulation relative to not using a skin protectant. RESULTS: Patients' mean age was 80.2 years and 61% were female. Sixty-five per cent (n=166) of Cavilon patients received NSBF, and 35% received DBC. Between 6% and 9% of VLUs were healed at 6 months and 53-66% became infected. Healing was affected by a patient's age (OR: 0.944 for each additional year), but not by gender, level of exudate or wound size. There was a significantly greater reduction in wound size among patients in the NSBF group than in the other two groups (p<0.001). Additionally, there was no significant difference in the initial wound size of those VLUs that did and did not heal in the two Cavilon groups; however, initial size of the VLUs that healed in the control group was significantly smaller than those that did not (p<0.001). Resource use was similar between the three groups. Patients were predominantly managed by practice nurses, with a mean 37-38 nurse visits over the study period. Patients' dressings were changed, on average, every 4-5 days, with a mean of 3 dressings under a compression bandage. The total 6-monthly NHS cost of managing a VLU was ~£2200. Practice nurse visits were the primary cost driver, accounting for up to 58% of the 6-monthly NHS cost, whereas dressings accounted for <10% of the cost. CONCLUSION: Use of NSBF leads to significantly greater wound size reduction than that observed in the other two groups and may facilitate the healing of larger wounds without increasing costs. Hence, use of NSBF for peri-wound skin protection in patients with exuding VLUs is the preferred treatment strategy. DECLARATION OF INTEREST: This study was sponsored by 3M Health Care, manufacturers of Cavillon NSBF and Cavillon DBC. However, the authors have no other conflicts of interest that are directly relevant to the content of this manuscript, which remains their sole responsibility.

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OBJECTIVE: To summarise the clinical and economic literature relating to the effect of Cavilon No Sting Barrier Film on the incidence of incontinence-associated dermatitis, which is a risk factor for pressure ulceration and exudate-related peri-wound skin damage. METHOD: A systematic literature search was performed using available computerised databases for publications on Cavilon barrier film and other relevant terms. Six clinical studies were identified providing data on 1,563 patients treated with the barrier film or a comparator. The publications comprised prospective studies, randomised and non-randomised studies, multicentre trials, single-centre reports and a volunteer study. Due to the nature of the comparators, five studies were open-label. Differences in methodology and outcomes made a qualitative review the most appropriate analysis. RESULTS: The barrier film was at least as effective as petroleum ointments and more effective than zinc oxide formulations in preventing incontinence-associated dermatitis. The barrier film was also effective in peri-wound skin protection, although its clinical efficacy was not significantly different to that of petroleum ointments and zinc oxide formulations. Nevertheless, the barrier film was more cost-effective than either petroleum ointments or zinc oxide formulations in managing incontinence-associated dermatitis and peri-wound skin protection, largely due to savings in nursing time. CONCLUSION: The barrier film is at least as clinically effective and potentially more cost-effective in incontinence-associated dermatitis prophylaxis and peri-wound skin protection than petroleum ointments or zinc oxide formulations, releasing health care resources for alternative use. Further studies are required to quantify the relative efficacy and cost-effectiveness of the barrier film and other barrier formulations in different clinical settings and enhance the quality of the evidence base.

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OBJECTIVE: To assess the cost-effectiveness of using amelogenin plus compression bandaging versus compression bandaging alone in treating non-healing venous leg ulcers (VLUs) of over six months duration, from the perspective of the national health service in England. METHOD: A 12-month Markov model was constructed that depicted the management of a chronic, non-healing VLU of over six months duration. The model considers the decision by a clinician to treat a recalcitrant VLU with amelogenin plus compression bandaging or compression bandaging alone, and was used to estimate the relative cost-effectiveness of amelogenin plus compression bandaging at 20062007 prices. RESULTS: According to the model, 60% of all wounds treated with amelogenin plus compression bandaging are expected to heal within 12 months of the start of treatment compared with 41% of wounds treated with compression bandaging alone (p<0.01). Additionally, 23% of all amelogenin-treated wounds are expected to improve compared with 18% of wounds in the compression bandaging alone group. This difference in effectiveness between the two groups is expected to lead to a 7% improvement in health gain among amelogenin-treated patients when compared with those treated with compression bandaging alone (0.800 versus 0.746 QALYs; p<0.01) at 12 months after the start of treatment. Use of amelogenin is expected to lead a 10% reduction in NHS cost over 12 months from pound4,261 (95% CI: pound3,409; pound5,114) to pound3,816 (95% CI: pound3,227; pound4,405), due in part to a reduction in the requirement for nurse visits. Hence, amelogenin plus compression bandaging was found to be a dominant treatment. Moreover, use of amelogenin is expected to free-up NHS resources for alternative use within the system. CONCLUSION: Within the models limitations, amelogenin plus compression bandaging is expected to afford the NHS a cost-effective dressing compared with compression bandaging alone in the management of chronic non-healing VLUs of more than six months duration. DECLARATION OF INTEREST: This study was sponsored by Mölnlycke Heath Care. The authors have no other conflicts of interest that are directly relevant to the content of this manuscript.

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OBJECTIVE: To estimate the resource costs of providing wound care for the 488,000 catchment population of the Bradford and Airedale primary care trust (PCT). METHOD: A wound survey was carried out over a one-week period in March 2007 covering three hospitals in two acute trusts, district nurses, nursing homes and residential homes within the geographical area defined by the PCT. The survey included information on the frequency of dressing change, treatment time and district nurse travel time. The resource costs of wound care in the PCT were estimated by combining this information with representative costs for the UK National Health Service and information on dressing spend. RESULTS: Prevalence of patients with a wound was 3.55 per 1000 population. The majority of wounds were surgical/trauma (48%), leg/foot (28%) and pressure ulcers (21%). Prevalence of wounds among hospital inpatients was 30.7%. Of these, 11.6% were pressure ulcers, of which 66% were hospital-acquired. The attributable cost of wound care in 2006-2007 was pounds 9.89 million: pounds 2.03 million per 100,000 population and 1.44% of the local health-care budget. Costs included pounds 1.69 million spending on dressings, 45.4 full-time nurses (valued at pounds 3.076 million) and 60-61 acute hospital beds (valued at pounds 5.13 million). CONCLUSION: The cost of wound care is significant. The most important components are the costs of wound-related hospitalisation and the opportunity cost of nurse time. The 32% of patients treated in hospital accounted for 63% of total costs. Putting in place care pathways to avoid hospitalisation and avoiding the development of hospital-acquired pressure ulcers and other wound complications are important ways to reduce costs. DECLARATION OF INTEREST: John Posnett is an employee of Smith & Nephew.

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OBJECTIVE: To undertake a follow-up of patients with hard-to-heal venous leg ulcers (VLUs) who had participated in a randomised controlled trial in which they had been treated with either compression therapy in combination with amelogenin extracellular matrix protein or compression therapy alone for 12 weeks or until their ulcers had healed, whichever occurred first. METHOD: Patients were randomised to receive either high compression therapy plus amelogenin (n=42) or high compression therapy alone (n=41) for a period up to and including 12 weeks. The method and initial findings are detailed in an earlier paper. Twelve weeks after the final visit, the patients were followed up and the wounds were re-evaluated. RESULTS: The initial results demonstrated clinically and statistically significant benefits for the patients in the amelogenin group. The results of the follow-up showed that the successful healing response had been maintained. Significantly more patients continued to show a reduction in ulcer size from baseline in the amelogenin-treated group versus the control group (p=0.02), and there was a statistically significant (p=0.01) larger reduction in the amelogenin-treated group. This group also had a significantly (p=0.02) higher percentage of patients with decreases in wound size. The overall number of patients with healed wounds was greater (n=9) in the amelogenin-treated group than in the control group (n=3). Pain continued to be significantly reduced in the amelogenin-treated group compared with the control group (p=0.001). CONCLUSION: Amelogenin therapy in conjunction with high compression therapy was beneficial in the treatment of hard-to-heal VLUs when compared with treatment with high compression alone. These beneficial effects were maintained post-treatment and were identified at follow-up.

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OBJECTIVE: To compare hard-to-heal venous leg ulcers treated with compression therapy alone versus compression therapy with amelogenin protein. Parameters used were: percentage reduction in wound size, number of improved ulcers, pain related to the disease and at dressing changes, amount and nature of exudate, and the safety and tolerability of the two treatments. METHOD: This was an open randomised comparative parallel group multicentre investigation with a three-week run-in period. Inclusion criteria included adult, mobile patients with hard-to-heal venous leg ulcers that had been treated with compression therapy for at least one month prior to screening. The ulcers had to be at least six months old, with a surface area at inclusion of 10-30cm2, and not demonstrating excessive exudate or signs of infection. At the end of the run-in period, additional criteria for eligibility, such as change in wound area of +/- > or = 50% and a wound area between 8cm2 and 36cm2 were applied. Patients were randomised to treatment with amelogenin plus high compression bandaging or high compression bandaging alone. All participants received high compression bandaging therapy one month prior to and during the three-week run-in period, as well as throughout the 12 weeks of active treatment. RESULTS: Eighty-three patients were randomised and received treatment: 42 with high compression plus amelogenin (amelogenin group) and 41 to high compression therapy alone (control group). The amelogenin group had a greater percentage reduction in ulcer size (mean - 33.1%) compared with the control group (mean - 11.07%) from baseline to the last visit (p = 0.06). The number of improved ulcers was significantly greater (p = 0.01) in the amelogenin group than in the control group. Compensating for baseline characteristics by multiple regression resulted in a statistically significant (p = 0.03) larger reduction in change in ulcer size in the amelogenin group. Statistically significant differences in favour of the amelogenin group were also found for reduction in ulcer-related pain (p = 0.01), reduction in pain at dressing changes (p = 0.02) and the proportion of patients with 'none' or 'low' levels of exudate (p = 0.01). CONCLUSION: The combination of amelogenin with high compression promotes the healing process in hard-to-heal ulcers. Application of amelogenin as an adjunct to compression results in a significant reduction in ulcer size, improvement in the state of ulcers, reduced pain and a larger proportion of ulcers with low levels of exudate. The results of this study are statistically and clinically significant.

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BACKGROUND: Studies relating to the ethnic origin of patients with an abdominal aortic aneurysm (AAA) are few and are mainly concerned with the differences between black and white Americans. The purpose of this study was to determine whether the incidence of AAA among the Asian population of Bradford is different from that in the Caucasian population. METHODS: A retrospective study of patients with an AAA was carried out between 1990 and 1997 using data collected by the Patient Administrative Service, personal databases of the vascular consultants and theatre records. Information about the ethnic composition of the population of Bradford was obtained from the 1991 national census. Demographic data, including ethnic origin and clinical details, were obtained from patient notes. RESULTS: Two hundred and thirty-three patients with an AAA were identified during the study interval. The Asian population comprised 14.0 per cent of the total population of Bradford. Twenty-eight AAAs would be expected per year. All of the aneurysms identified occurred in the Caucasian population and none in the Asian community. CONCLUSION: These early results suggest that AAA is rare among the Asian population.

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