MulTI-domain self-management in older People wiTh OstEoarthritis and multi-morbidities: protocol for the TIPTOE randomised controlled trial.

BACKGROUND: Four out of five people living with osteoarthritis (OA) also suffer with at least one other long-term health condition. The complex interaction between OA and multiple long-term conditions (MLTCs) can result in difficulties with self-care, restricted mobility, pain, anxiety, depression and reduced quality of life. The aim of the MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE) trial is to evaluate the clinical and cost-effectiveness of the Living Well self-management support intervention, co-designed with people living with OA, integrated into usual care, in comparison to usual care alone. METHODS: TIPTOE is a multi-centre, two-arm, individually randomised controlled trial where 824 individuals over 65 years old with knee and/or hip joint pain from their OA affected joint and at least one other long-term health condition will be randomised to receive either the Living Well Self-Management support intervention or usual care. Eligible participants can self-refer onto the trial via a website or be referred via NHS services across Wales and England. Those randomised to receive the Living Well support intervention will be offered up to six one-to-one coaching sessions with a TIPTOE-trained healthcare practitioner and a co-designed book. Participants will be encouraged to nominate a support person to assist them throughout the study. All participants will complete a series of self-reported outcome measures at baseline and 6- and 12-month follow-up. The primary outcome is symptoms and quality of life as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ). Routine data will be used to evaluate health resource use. A mixed methods process evaluation will be conducted alongside the trial to inform future implementation should the TIPTOE intervention be found both clinically and cost-effective. An embedded 'Study Within A Project' (SWAP) will explore and address barriers to the inclusion of under-served patient groups (e.g. oldest old, low socioeconomic groups, ethnic groups). DISCUSSION: TIPTOE will evaluate the clinical and cost-effectiveness of a co-designed, living well personalised self-management support intervention for older individuals with knee and/or hip OA and MLTCs. The trial has been designed to maximise inclusivity and access. TRIAL REGISTRATION: ISRCTN 16024745 . Registered on October 16, 2023.

A cross-sector systematic review and synthesis of knowledge on telemedicine interventions in chronic wound management-Implications from a system perspective.

Based on initially identified needs for further telemedicine (TM) and chronic wound management research, the objective of this article is twofold: to conduct a systematic review of existing knowledge on TM interventions in chronic wound management-including barriers and opportunities-across the specialist and primary care sectors, and to incorporate the review findings into a system framework that can be further developed and validated through empirical data. We conclude that there is a pressing need for broader and more comprehensive empirical explorations into quality improvement and integration of TM in chronic wound management, including using system frameworks that can capture cross-sector system perspectives and associated implications. Of practical consideration, we suggest that the design and execution of TM improvement interventions and associated research projects should be conducted in close cooperation with managers and practitioners knowledgeable about barriers and opportunities that can influence the implementation of important interventions within chronic wound management.

Measuring progress to healing: A challenge and an opportunity.

Complete healing is problematic as an endpoint for evaluating interventions for wound healing. The great heterogeneity of wounds makes it difficult to match groups, and this is only possible with multivariate stratification and/or very large numbers of subjects. The substantial time taken for wounds to heal necessitates a very lengthy study. Consequently, high quality randomised controlled trials demonstrating an effect of an intervention to a satisfactory level of statistical significance and with a satisfactory level of generalisability are extremely rare. This study determines that the healing of venous leg ulcers receiving multi-component compression bandaging follows a linear trajectory over a 4-week period, as measured by gross area healed, percentage area healed, and advance of the wound margin. The linear trajectories of these surrogates make it possible to identify an acceleration in healing resulting from an intervention, and allows self-controlled or crossover designs with attendant advantages of statistical power and speed. Of the metrics investigated, wound margin advance was the most linear, and was also independent of initial ulcer size.

Two-layer reduced compression system for lower limb wounds: a non-comparative evaluation.

Leg ulceration is a debilitating condition in which various factors play a role in determining patients' quality of life (QoL), and compression therapy has been shown to improve QoL. The 3M Coban 2 Lite Compression System provides reduced compression (25-30 mmHg) ideal for patients with painful venous leg ulcers (VLU) who are unable to tolerate high-strength compression or those with mixed-aetiology leg ulcers (MLU) who have an ankle-brachial pressure index (ABPI)≥0.5. This non-comparative evaluation aims to report the initial clinical experiences with 3M Coban 2 Lite and evaluate the performance of this two-layer reduced compression bandage system in treating chronic VLUs and MLUs. In total, 30 patients (12 men (40%); mean age=68.5 years) were enroled for evaluation. The duration of the chronic wounds was 28 months (range=1.5-144 months); 16 patients had VLUs, while 14 had MLUs. Complete healing was achieved in 6 (20%) patients, and an overall mean reduction in wound surface area (4.11 cm2) was observed between the baseline and study endpoint (16 weeks). Thus, 3M Coban 2 Lite seems safe and effective for treating painful VLUs and MLUs in patients unable to tolerate high-strength compression.

Management of incontinence-associated dermatitis patients using a skin protectant in acute care: a case series.

OBJECTIVE: Incontinence-associated dermatitis (IAD) is a common type of irritant contact dermatitis. It is categorised by persistent erythema and can be associated with denudation and/or colonisation and infection. IAD is challenging to treat and affects 3.4-50% of patients. This case series evaluates a novel, elastomeric, advanced skin protectant (3M Cavilon Advanced Skin Protectant) in a UK acute health-care setting, for the management of IAD in patients suffering from moisture-associated skin damage (MASD) in the sacral/genital area. METHOD: The patient's skin was assessed by clinicians using the GLOBIAD classification tool at the point of recruitment and to monitor progress throughout the study period. The product was applied as a single layer in accordance with the instructions for use. Patients, when able, were asked to assess their own pain level using the Wong-Baker FACES pain scale. Photographs were taken as part of the ongoing assessment. RESULTS: The skin protectant was used on average every 2.28 days. Of the 18 IAD patients recruited, 79% (n=11) were classified as IAD-free, based on the GLOBIAD categorisation tool, by the end of the evaluation period. Skin deterioration during the evaluation period was seen in one patient (6%), and of the patients able to complete pain assessments, 55% (n=6) reported a reduction in pain. CONCLUSION: These results suggest that the elastomeric skin protectant, applied every three days, plays a role in the improvement of IAD. The skin protectant adheres to wet and weeping partial-thickness wounds and may aid IAD management. Reducing application to every third day supports a change in practice which may offer benefits to patients and caregivers.

A prospective pilot study of thigh-administered intermittent pneumatic compression in the management of hard-to-heal lower limb venous and mixed aetiology ulcers.

This was a prospective observational pilot study of a unique intermittent pneumatic compression (IPC) device designed to be applied in the thigh region of the affected limb in patients with lower limb ulceration of both venous and mixed (venous and arterial) aetiologies. This compression system consists of a circumferential three-chamber thigh garment and an electronic pneumatic compression pump operating over a repeated 4-minute cycle. Patients were recruited from outpatient wound clinics. Those recruited were treated with standard therapy in addition to IPC, which was applied for 2 hours per day, and followed up for a total of 8 weeks. The primary objective of the study was to examine the effects of IPC on wound healing over an 8-week period. The other objectives were to assess patients' experiences of pain and the acceptability of IPC device. Twenty-one patients were recruited, and wounds progressed towards healing in 95.24% (20/21) of the patients. Pain scores decreased in 83.33% (15/18) of the patients. Most patients felt that the thigh-applied IPC device was comfortable and easy to apply and remove. The thigh-administered IPC device can be recommended for use in routine clinical practice, especially when other treatment options are limited.

Neuromuscular electrostimulation on lower limb wounds.

The geko™ is a disposable neuromuscular electrostimulation (NMES) device intended to increase blood circulation and promote wound healing in a range of lower limb conditions. The purpose of this case series was to evaluate the therapeutic effect of the geko device on wound healing outcomes over an 8-week period. Thirty patients with non-healing wounds (≥ 12-week duration) of either venous leg ulceration (VLU), mixed leg ulceration (MLU) or diabetic foot ulceration aetiology were recruited from a local outpatient wound clinic in the South Wales area. Over the 8 weeks 2 participants (8%) achieved complete re-epithelialisation between baseline and endpoint. Mean wound surface area decreased (7.6 cm2) and there was an increase of 21% in the mean percentage of granulation tissue in the wound bed. Pain levels reduced in 52% of patients who completed the study, but the extent of oedema reduction was difficult to establish given that 76% of the cohort were treated with a form of compression as part of standard care. The findings support the use of the therapy in patients with painful VLUs and MLUs, but further research needs to be conducted to establish the generalisability of the findings to the wider population of patients living with chronic wounds of differing aetiology in the lower limb.

Use of a gelling fibre dressing in complex surgical or chronic wounds: a case series.

OBJECTIVE: To evaluate the safety and performance of a gelling fibre dressing, with respect to wound exudate management, maceration and periwound skin conditions. METHOD: Complex (non-healing) surgical or chronic wounds healing by secondary intention were treated with a gelling fibre dressing (Biosorb, Acelity) as part of a prospective, two-centre case series product evaluation study. Dressing performance was evaluated at each change, and weekly for up to four weeks or until the wound healed, if this was in less than four weeks. The main outcome measure was dressing performance, wound bed and periwound skin condition. RESULTS: A total of 15 patients, aged 26-87 years, were enrolled; 10 patients (66.7%) presented with chronic wounds including venous leg ulcers (VLUs), arterial leg ulcer, one mixed leg ulcer, pressure ulcer (PU), and diabetic foot ulcers (DFUs). The remaining wounds (33.3%) were postsurgical complex wounds healing by secondary intention, located in the upper leg, foot, abdomen, and sacrum. Mean wound area was 22.6±36.6cm2 (range: 1.3-144.0cm2). Treated wounds showed complete granulation in eight (53.0%) wounds, 75% granulation coverage in two (13.3%) wounds, 50% coverage in three (20.3%), and 25% coverage in two (13.3%) wounds. Patients evaluated the dressing effectiveness as 'excellent' or 'very good' in 45% of cases, 'moderate' in 45%, and 'poor' in 10% of cases. Results of Visual Analogue Scale (VAS) showed 70% of patients rated their pain as 'low' and 30% as 'moderate' at dressing removal. Clinicians' evaluation of dressing ability to absorb and retain wound exudate was rated 'excellent' or 'very good' in 80% of cases, and moderate in 20% and poor in 10% of cases. Overall, clinicians' impression of the dressing performance was reported as 'excellent' or 'very good' in 80% of cases and 'moderate' in 20% of cases. No patient had to be removed from the study due to adverse events directly related to the dressing or its performance. CONCLUSION: These clinical findings suggest the new gelling fibre dressing to be safe and effective in wound treatment of complex (non-healing) surgical or chronic wounds, to manage exudate effectively, and to optimise the conditions of wounds healing by secondary intention.

National audit of pressure ulcers and incontinence-associated dermatitis in hospitals across Wales: a cross-sectional study.

OBJECTIVE: The Chief Nurse National Health Service Wales initiated a national survey of acute and community hospital patients in Wales to identify the prevalence of pressure ulcers and incontinence-associated dermatitis. METHODS: Teams of two nurses working independently assessed the skin of each inpatient who consented to having their skin observed. RESULTS: Over 28 September 2015 to 2nd October 2015, 8365 patients were assessed across 66 hospitals with 748 (8.9%) found to have pressure ulcers. Not all patients had their skin inspected with all mental health patients exempt from this part of the audit along with others who did not consent or were too ill. Of the patients with pressure ulcers, 593 (79.3%) had their skin inspected with 158 new pressure ulcers encountered that were not known to ward staff, while 152 pressure ulcers were incorrectly categorised by the ward teams. Incontinence-associated dermatitis was encountered in 360 patients (4.3%), while medical device-related pressure ulcers were rare (n=33). The support surfaces used while patients were in bed were also recorded to provide a baseline against which future changes in equipment procurement could be assessed. The presence of other wounds was also recorded with 2537 (30.3%) of all hospital patients having one or more skin wounds. CONCLUSIONS: This survey has demonstrated that although complex, it is feasible to undertake national surveys of pressure ulcers, incontinence-associated dermatitis and other wounds providing comprehensive and accurate data to help plan improvements in wound care across Wales.

New Surfactant-based Dressing Product to Improve Wound Closure Rates of Nonhealing Wounds: A European Multicenter Study Including 1036 Patients.

OBJECTIVE: A new surfactant-based biomaterial containing the antimicrobial 1% silver sulfadiazine (SSD) was developed at the University of Virginia (Charlottesville, VA) to improve outcomes for nonhealing wounds. This study's objective was to clinically test the wound care outcomes of the new surfactant-based antimicrobial wound dressing (SAWD) in a multicenter trial. METHODS AND MATERIALS: This cohort study enrolled 1036 patients with any nonhealing wound of > 3 months duration not responding to standard-of-care treatments from 10 wound care centers in 7 European countries. The SAWD was used for all wound types at all stages of complexity, healing, and severity. Data collection ranged from 6 months to 2 years and measured the percentage of patients achieving wound closure and time to complete closure. RESULTS: Of the 1036 patients, 70% achieved wound closure, 24.6% were still in treatment at data collection, and 5.4% had a therapy change. The majority (56%) of these non-healing wounds achieved wound closure within 11 weeks. Patients were treated with the SAWD for 3 weeks to more than 1 year with no complications or adverse effects from long-term SSD antimicrobial use. CONCLUSION: Ten centers concluded that the new SAWD provided positive results (improved wound closure rates, reduction of inflammation, pain, and odor), improvements in clinical application (faster and easier dressing change), and improved patient compliance.

Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trial.

'Hard-to-heal' wounds are those which fail to heal with standard therapy in an orderly and timely manner and may warrant the use of advanced treatments such as non-contact low-frequency ultrasound (NLFU) therapy. This evaluator-blinded, single-site, randomised controlled trial, compared NLFU in addition to UK standard of care [SOC: (NLFU + SOC)] three times a week, with SOC alone at least once a week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomised patients completed treatment (17 NLFU + SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU + SOC patients showed a -47% (SD: 38%) change in wound area; SOC, -39% (38%) change; and difference, -7·4% [95% confidence intervals (CIs) -33·4-18·6; P = 0·565]. The median number of infections per patient was two in both arms of the study and change in quality of life (QoL) scores was not significant (P = 0·490). NLFU + SOC patients reported a substantial mean (SD) reduction in pain score of -14·4 (14·9) points, SOC patients' pain scores reduced by -5·3 (14·8); the difference was -9·1 (P = 0·078). Results demonstrated the importance of high-quality wound care. Outcome measures favoured NLFU + SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow-up may reveal NLFU-related improvements not identified in this study.

Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers.

The objective of this study was to investigate the safety and performance of AQUACEL™ Ag+ dressing, a wound dressing containing a combination of anti-biofilm and antimicrobial agents, in the management of chronic wounds. Patients (n = 42) with venous leg ulcers exhibiting signs of clinical infection were treated for 4 weeks with AQUACEL™ Ag+ dressing, followed by management with AQUACEL™ wound dressings for 4 weeks. Wound progression, wound size, ulcer pain and clinical evolution of the wound were assessed for up to 8 weeks. Adverse events were recorded throughout the study. AQUACEL™ Ag+ dressing had an acceptable safety profile, with only one patient discontinuing from the study, because of a non-treatment-related adverse event. After 8 weeks, substantial wound improvements were observed: 5 patients (11·9%) had healed ulcers and 32 patients (76·2%) showed improvement in ulcer condition. The mean ulcer size had reduced by 54·5%. Patients reported less pain as the study progressed. Notable improvements were observed in patients with ulcers that were considered to require treatment with systemic antibiotics or topical antimicrobials at baseline (n = 10), with a mean 70·2% reduction in wound area. These data indicate that AQUACEL™ Ag+ dressing has an acceptable safety profile in the management of venous leg ulcers that may be impeded by biofilm.

Clinical Evaluation of a Novel Topical Negative Pressure Device in Promoting Healing in Chronic Wounds.

Aim: This observational study evaluated the use of a novel, ultraportable, mechanically powered topical negative pressure device in promoting healing in chronic wounds, including venous and mixed etiology leg ulcers and neuropathic foot ulcers. Materials and Methods: Evaluable patients (n=37) received treatment with the SNaP® Wound Care System for up to 6 weeks. The primary objective was percentage change in wound size, with secondary objectives of clinical assessment of wound parameters, ease of use, and impact on quality of life. Results: A 42.64% mean percentage decrease in wound area was observed, with an overall decrease for each wound etiology subgroup. Increased granulation tissue, decreased exudate levels, and decreased wound pain were reported. Quality-of-life scores increased overall, and the device was easy to use, comfortable, portable, and inconspicuous. Conclusion: The SNaP Wound Care System has the potential to promote healing in chronic wounds of different etiologies.

Randomized trial of antimicrobial-coated sutures to prevent surgical site infection after breast cancer surgery.

BACKGROUND: Surgical site infection (SSI) is the fourth commonest healthcare-associated infection and complicates at least 5% of open operations. In a randomized clinical trial, antimicrobial-coated sutures were compared with their conventional counterparts, polyglactin and poliglecaprone, for skin closure after breast cancer surgery to assess their role in reducing the rate of SSI. METHODS: Between November 2008 and February 2011, 150 female patients presenting with breast cancer to a single center were randomized to skin closure with antimicrobial-coated or plain sutures. Postoperatively, SSI was defined using the U.S. Centers for Disease Control and Prevention (CDC) definitions and scored using the ASEPSIS or Southampton systems by trained, blinded observers with close post-discharge surveillance and patient diaries. Surgeons and patients were blinded to the type of suture used. RESULTS: Using CDC criteria, the overall rate of SSI was 18.9% at six weeks. Six patients (4.7%) needed intervention or readmission for SSI. Skin closure with antimicrobial sutures showed a non-statistically significant reduction in the SSI rate, to 15.2%, compared with conventional sutures (22.9%). A uniform tendency for fewer SSIs in the antimicrobial-coated suture group was found using ASEPSIS and Southampton scores, but again, the difference was not statistically significant. CONCLUSION: The previously reported high rate of SSI related to breast surgery was confirmed. Using statistical modeling and earlier reports, the study was powered to show a difference using ASEPSIS scores, but the modification used in this trial failed to find a difference. Finding a statistically significant difference would have needed two to three times the number of patients recruited. Further evaluation of antimicrobial-coated sutures is merited, particularly if used as part of a care bundle to reduce SSI after breast cancer surgery.

Early use of negative pressure therapy in combination with silver dressings in a difficult breast abscess.

Combining silver-based dressings with negative pressure therapy after radical excision of chronically infected breast disease is a novel application of two technologies. One patient with complex, chronic, infected breast disease underwent radical excision of the affected area and was treated early with a combination of silver-based dressings and topical negative pressure therapy. The wound was then assessed sequentially using clinical measurements of wound area and depth, pain severity scores and level of exudation. It is possible to combine accepted techniques with modern dressing technologies that result in a positive outcome. In this case, the combination of a silver-based dressing with negative pressure therapy following radical excision proved safe and was well tolerated by the patient. Full epithelisation of the wound was achieved and there was no recurrence of the infection for the duration of the treatment.

Adherence to a 2-layer compression system for chronic venous ulceration.

Adherence to compression therapy is fundamental for healing venous leg ulcers (Moffatt, 2004). The aim of this study was to investigate adherence and comfort associated with using a 2-layer compression system over a 6-week period for the management of chronic venous leg ulceration in patients with a history of non-adherence to other compression systems. Self-report rating scales were completed each week by the patients to record adherence and comfort of the compression system, while condition and ease of use of the system were recorded each week by the nurses involved in their care. The majority of the patients reported wearing the compression system for 75% of the time and were considered by the nurses to be 'fully adherent' for 80% of the time. Comfort and ease of use were rated highly by the majority of patients and nurses respectively.

Evaluating the effectiveness of Tegapore wound-contact material.

During wound healing, new-forming granulation tissue is often extremely fragile and can be easily disrupted during dressing changes. This can lead to a delay in the completion of wound healing and increased pain and discomfort for the patient (European Wound Management Association, 2002; Fear, 2002).