Improving the quality of clinical research on chronic wound infection treatment: expert-based recommendations.

OBJECTIVE:: To produce recommendations for the design of reliable and informative clinical investigations in chronic wound infection. METHOD:: A multidisciplinary panel of international experts from four countries (Italy, UK, Ireland and the US) were involved in a detailed, semi-structured discussion on how to better select and describe a target population, interventions and outcomes, and which infection-related criteria to apply in order to achieve a high-quality trial. Consent among the experts was measured using the Delphi method and GRADE Working Group suggestions. The project was fully supported by AISLeC 2016 (Italian Nursing Society for Wound Care Study). RESULTS:: In total, 37 recommendations achieved substantial agreement among the experts; 10 concerned the most appropriate description and selection of a target population, four related to interventions and 15 to outcomes. A further eight statements about critical methodological points were approved. CONCLUSION:: Developing recommendations in a systematic manner through a representative group of experts could generate tools for improving the design of clinical trials in this challenging area.

NHS generic project: response from the wound care community.

This series of letters outlines the response from MA Healthcare, key opinion leaders, and industry to the news that the Government is planning to introduce a generic project for wound dressings, limiting products to three main suppliers.

Comparing ostomates' perceptions of hydrocolloid and silicone seals: a survey.

Most stoma flanges are made of hydrocolloid material. Hydrocolloid is a hydrophilic material that attracts water, potentially resulting in moisture becoming trapped between the flange and skin. Also, as hydrocolloids are absorbent, the material breaks down over time, and there is a risk that some of the adhesive can remain on the skin on removal. Unlike hydrocolloids, silicone comprises fully cross-linked silicone polymers whose properties have been engineered to manage moisture without breaking down (i.e. manage the transepidermal water loss (TEWL)). A questionnaire survey was undertaken to determine ostomates' perceptions of silicone versus hydrocolloid stoma care products (both flanges and seals). The survey was sent to 229 ostomates who had used silicone seals, of whom 78 returned it (a response rate of 34%). The results suggest that use of the silicone seals resulted in a improvement in the condition of the peristomal skin condition, reduced leakage and increased wear time. Further research into this area is required.

Safe, long-term management of bioburden that helps promote healing Evidence review of DACC technology.

Unlike common antimicrobial dressings, the Cutimed Sorbact range does not kill pathogens, but instead binds them to its surface, so they can be safely removed at dressing change. As a result, it can be used long term with minimal risk of side effects. This supplement describes the evidence base on the efficacy of DACC technology.

In vitro and clinical experience of Cutimed Sorbact: the evidence base.

In the previous chapter, Keith Cutting and James McGuire explored the link between infection and wound chronicity and explained how Cutimed Sorbact can be used to promote healing in chronic wounds. The following sections summarise the existing evidence for the Cutimed Sorbact range of dressings.

Super-absorbent polymer dressings and sub-bandage pressure: a concern?

Graduated external compression lies at the heart of effective management of venous leg ulceration by reducing oedema and supporting venous return to the heart.

Fundamentals of randomized clinical trials in wound care: reporting standards.

In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care. Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta-analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.

Bacterial growth kinetics under a novel flexible methacrylate dressing serving as a drug delivery vehicle for antiseptics.

A flexible methacrylate powder dressing (Altrazeal®) transforms into a wound contour conforming matrix once in contact with wound exudate. We hypothesised that it may also serve as a drug delivery vehicle for antiseptics. The antimicrobial efficacy and influence on bacterial growth kinetics in combination with three antiseptics was investigated in an in vitro porcine wound model. Standardized in vitro wounds were contaminated with Staphylococcus aureus (MRSA; ATCC 33591) and divided into six groups: no dressing (negative control), methacrylate dressing alone, and combinations with application of 0.02% Polyhexamethylene Biguanide (PHMB), 0.4% PHMB, 0.1% PHMB + 0.1% betaine, 7.7 mg/mL Povidone-iodine (PVP-iodine), and 0.1% Octenidine-dihydrochloride (OCT) + 2% phenoxyethanol. Bacterial load per gram tissue was measured over five days. The highest reduction was observed with PVP-iodine at 24 h to log10 1.43 cfu/g, followed by OCT at 48 h to log10 2.41 cfu/g. Whilst 0.02% PHMB resulted in a stable bacterial load over 120 h to log10 4.00 cfu/g over 120 h, 0.1% PHMB + 0.1% betaine inhibited growth during the first 48 h, with slightly increasing bacterial numbers up to log10 5.38 cfu/g at 120 h. These results indicate that this flexible methacrylate dressing can be loaded with various antiseptics serving as drug delivery system. Depending on the selected combination, an individually shaped and controlled antibacterial effect may be achieved using the same type of wound dressing.

Fundamentals of randomized clinical trials in wound care: design and conduct.

The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes. This article proposes strategies for improving the evidence base for wound care decision making.

Microbiology of the skin and the role of biofilms in infection.

The integrity of human skin is central to the prevention of infection. Acute and chronic wounds can develop when the integrity of skin as a barrier to infection is disrupted. As a multi-functional organ, skin possesses important biochemical and physical properties that influence its microbiology. These properties include a slightly acidic pH, a low moisture content, a high lipid content (which results in increased hydrophobicity) and the presence of antimicrobial peptides. Such factors have a role to play in preventing exogenous microbial colonisation and subsequent infection. In addition, the properties of skin both select for and enhance colonisation and biofilm formation by certain 'beneficial' micro-organisms. These beneficial micro-organisms can provide further protection against colonisation by potential pathogens, a process known as colonisation resistance. The aim of this paper is to summarise the microflora of skin and wounds, highlighting the role of certain micro-organisms and biofilms in associated infections.

Super-absorbent dressings: how do they perform in vitro?

The free swell and absorption capacity under compression of six wound dressings that are indicated for moderately to highly exuding wounds was investigated. Measuring in vitro the absorptive capacity and retention under compression is important in terms of clinical efficacy and efficiency. This in vitro comparative study demonstrated that sorbion sachet EXTRA had the highest free swell capacity of the six test dressings and absorbed more than twice the volume (126%) of the test solution than its nearest competitor. When measuring capacity under compression, sorbion sachet EXTRA absorbed 88% more fluid than the nearest competitor.