The role community-based healthcare providers play in managing hard-to-heal wounds.

It is common for community-based healthcare providers (CHPs)-many of whom have not received specialised training in wound care-to deliver initial and ongoing management for various wound types and diverse populations. Wounds in any setting can rapidly transition to a stalled, hard-to-heal wound (HTHW) that is not following a normal healing trajectory. Failure to recognise or address issues that cause delayed healing can lead to increased costs, healthcare utilisation and suffering. To encourage early intervention by CHPs, a panel of wound care experts developed actionable evidence-based recommendations for CHPs delineating characteristics and appropriate care in identifying and treating HTHWs. A HTHW is a wound that fails to progress towards healing with standard therapy in an orderly and timely manner and should be referred to a qualified wound care provider (QWCP) for advanced assessment and diagnosis if not healed or reduced in size by 40%-50% within 4 weeks. HTHWs occur in patients with multiple comorbidities, and display increases in exudate, infection, devitalised tissue, maceration or pain, or no change in wound size. CHPs can play an important initial role by seeing the individual's HTHW risk, addressing local infection and providing an optimal wound environment. An easy-to-follow one-page table was developed for the CHP to systematically identify, evaluate and treat HTHWs, incorporating a basic toolkit with items easily obtainable in common office/clinic practice settings. A flow chart using visual HTHW clinical cues is also presented to address CHPs with different learning styles. These tools encourage delivery of appropriate early interventions that can improve overall healthcare efficiency and cost.

Use of Topical Gaseous Nitric Oxide/Plasma Energy in the Treatment of Recalcitrant Wounds.

Nitric oxide (NO) is involved in many biological functions and has been demonstrated to be important in wound healing. When delivered to a wound in its gaseous state, NO stimulates vasodilatation and angiogenesis, inhibits platelet and erythrocyte aggregation, reduces leukocyte adhesion, and is an important anti-inflammatory and antimicrobial agent. Many patients with chronic and hard-to-heal wounds have a deficiency of NO in their tissues ,which may contribute to slow and even arrested healing. However, it has been difficult to use NO for treatment because of its short half-life, which is measured in seconds. A recently developed device provides a way to generate NO and combine it with a stream of plasma energy, which extends its half-life to the point that it can provide a clinical effect. This device creates NO from the ambient air, and no other gases are needed. The combination of atmospheric oxygen and nitrogen at a high temperature generated by an electric arc results in NO and plasma energy (N2 + O2 = 2NO + 181 KJ energy). After generation, the NO/plasma energy-containing gas flow is cooled to 18-20°C, and NO is delivered to the tissues in a "dose" between 800 and 1000 ppm. When NO gas was combined with the plasma energy stream, the NO was found to penetrate intact skin or tissue up to 3cm to treat an underlying problem. Studies have shown that NO/plasma energy therapy promotes healing. This report summarizes current applications of this unique approach in the treatment of chronic, hard-to-heal and infected wounds.

Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial.

BACKGROUND: Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions. METHODS: We did an open-label, non-inferiority, randomised (1:1 with blocks of six), multicentre, phase 3 clinical trial comparing fully oral RC8 with RS8 in patients with early, limited Buruli ulcer lesions. There were four trial sites in hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè). Participants were included if they were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (caterories I and II) no larger than 10 cm in diameter. The trial was open label, and neither the investigators who took measurements of the lesions nor the attending doctors were masked to treatment assignment. The primary clinical endpoint was lesion healing (ie, full epithelialisation or stable scar) without recurrence at 52 weeks after start of antimicrobial therapy. The primary endpoint and safety were assessed in the intention-to-treat population. A sample size of 332 participants was calculated to detect inferiority of RC8 by a margin of 12%. This study was registered with ClinicalTrials.gov, NCT01659437. FINDINGS: Between Jan 1, 2013, and Dec 31, 2017, participants were recruited to the trial. We stopped recruitment after 310 participants. Median age of participants was 14 years (IQR 10-29) and 153 (52%) were female. 297 patients had PCR-confirmed Buruli ulcer; 151 (51%) were assigned to RS8 treatment, and 146 (49%) received oral RC8 treatment. In the RS8 group, lesions healed in 144 (95%, 95% CI 91 to 98) of 151 patients, whereas lesions healed in 140 (96%, 91 to 99) of 146 patients in the RC8 group. The difference in proportion, -0·5% (-5·2 to 4·2), was not significantly greater than zero (p=0·59), showing that RC8 treatment is non-inferior to RS8 treatment for lesion healing at 52 weeks. Treatment-related adverse events were recorded in 20 (13%) patients receiving RS8 and in nine (7%) patients receiving RC8. Most adverse events were grade 1-2, but one (1%) patient receiving RS8 developed serious ototoxicity and ended treatment after 6 weeks. No patients needed surgical resection. Four patients (two in each study group) had skin grafts. INTERPRETATION: Fully oral RC8 regimen was non-inferior to RS8 for treatment of early, limited Buruli ulcer and was associated with fewer adverse events. Therefore, we propose that fully oral RC8 should be the preferred therapy for early, limited lesions of Buruli ulcer. FUNDING: WHO with additional support from MAP International, American Leprosy Missions, Fondation Raoul Follereau France, Buruli ulcer Groningen Foundation, Sanofi-Pasteur, and BuruliVac.

Oxidized Regenerated Cellulose/Collagen Dressings: Review of Evidence and Recommendations.

OBJECTIVE: Healthcare systems are being challenged to manage increasing numbers of nonhealing wounds. Wound dressings are one of the first lines of defense in wound management, and numerous options exist. The oxidized regenerated cellulose (ORC)/collagen dressing may offer healthcare providers a robust and cost-effective tool for use in a variety of wounds. DESIGN: A multidisciplinary panel meeting was convened to discuss the use of ORC/collagen dressings in wound care and provide practice recommendations. A literature search was conducted to provide a brief review of the peer-reviewed studies published between January 2000 and March 2016 to inform the meeting. SETTING: A 2-day panel meeting convened in February 2017. PARTICIPANTS: Healthcare providers with experience using ORC/collagen dressings. This multidisciplinary panel of 15 experts in wound healing included podiatrists, wound care specialists (doctors, certified wound care nurses, and research scientists), and an orthopedist. RESULTS: The literature search identified 58 articles, a majority of which were low levels of evidence (69.3% were level 3 or lower). Panel members identified wound types, such as abrasions, burns, stalled wounds, diabetic foot ulcers, and pressure injuries, where ORC/collagen dressing use could be beneficial. Panel members then provided recommendations and technical pearls for the use of ORC/collagen dressings in practice. Barriers to ORC/collagen dressing use were discussed, and potential resolutions were offered. CONCLUSIONS: An ORC/collagen dressing can be a critical tool for clinicians to help manage a variety of wounds. Clinical and economic studies comparing standard-of-care dressings and plain collagen dressings to ORC/collagen dressings are needed.

Hematoma of the lower extremity: operative interventions in the wound clinic setting.

Hematoma in the soft tissue, a swelling in the tissue caused by bleeding, is not an uncommon occurrence following trauma or operative procedures. Hematomas of the extremities can be seen in as many as 33 per 10 000 individuals annually. Most hematomas are considered minor problems following the initial injury; however, accumulation of blood in the tissues can result in necrosis of the overlying skin due to increased tissue pressure. Even in the absence of increased tissue pressure, multiple cellular and biochemical changes that can result in tissue ischemia and necrosis have been identified. To avoid these significant complications, prompt recognition and operative evacuation of these hematomas should be performed. The author presents 2 cases of hematomas that were evacuated using local anesthesia in the wound clinic setting.

Treatment of osteomyelitis of the toes without amputation in the wound clinic setting.

Ulcers of the distal toe are common in patients with toe deformities and many times are complicated by osteomyelitis of the phalanx. Amputation of the toe is the standard treatment in many institutions; however, this can lead to abnormal biomechanics of the foot predisposing the patient to recurrent ulceration and further amputations, especially in patients with diabetes and those with neuropathy. It has been found that conservative, local operative procedures to remove the infected bone can avoid these complications and even avoid long-term antibiotic therapy. Many of these procedures can be performed in the wound clinic. To show its utility, a case report of this procedure and a small series of these patients treated in the wound clinic are presented.

Site assessments: early steps on the journey toward outcomes  .

Two volunteers who have continually dedicated time and effort to the Association for the Advancement of Wound Care (AAWC) and the Global Alliance and World Alliance for Wound and Lymphedema Care (WAWLC) describe perceptions of their life-changing overseas volunteer experiences. Learning and teaching became a two-way enrichment process, as volunteers and local healthcare leaders shared knowledge and practice pearls during lectures and hands-on workshops for managing wounds and lymphedema .

Infection and Inflammation in the Wound Environment: Addressing Issues of Delayed Wound Healing With Advanced Wound Dressings.

Impaired wound healing is estimated to affect about 2% of the US population, and a major goal of health care providers (HCPs) is to better understand delayed healing so they can effectively choose advanced wound dressings to manage these wounds. However, there are estimated to be more than 3000 dressing options available, making dressing selection an overwhelming burden. An expert panel of 7 HCPs experienced in diverse medical disciplines and 3 scientists convened to discuss the use of 2 families of dressings (silver-oxysalt [AgOx] dressings and oxidized regenerated cellulose/collagen [ORC/C] dressings) and delayed wound healing. Before the meeting, panelists reviewed 16 articles concerning the dressings, and 2 scientists presented on the topics of infection and inflammation in the wound environment, along with providing information about the dressing families, during the meeting. In addition, each HCP presented specific cases in which they had applied AgOx or ORC/C dressings and described how the dressing was used to manage stalled healing. After the meeting, the panelists and another HCP who was unable to attend the panel meeting provided insight and feedback for this publication, which provides an overview of the meeting. A major theme of this panel discussion was the need for a fundamental change in how HCPs approach wound care, especially for nonhealing wounds and underlying issues of infection and inflammation in the wound environment. Ultimately, the panel developed a decision-tree model for risk-stratifying patients based on their potential to have or develop these 2 underlying issues, followed by deciding on treatment options based on the status of infection and inflammation in the wound.

A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers.

This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.

Comparative Effectiveness of a Bioengineered Living Cellular Construct and Cryopreserved Cadaveric Skin Allograft for the Treatment of Venous Leg Ulcers in a Real-World Setting.

Objective: A variety of advanced biological therapies are available for the treatment of chronic wounds such as venous leg ulcers (VLUs), but real-world comparative effectiveness data that can help guide decisions around treatments are currently lacking. Approach: This analysis was designed to compare the effectiveness of a bioengineered living cellular construct (BLCC) to a cryopreserved cadaveric skin allograft (CCSA) for the treatment of VLUs. Treatment records were collected from a large wound care-specific electronic medical record database on 717 patients (799 VLUs) receiving treatment at 177 wound care centers. Ulcers ≥28 days duration, between ≥1 and < 40 cm2 that closed ≤40% within the 28 days before treatment were included. Results: Patient baseline demographics and wound characteristics were comparable between groups. The median time to wound closure was 52% faster with BLCC compared with CCSA (15 weeks vs. 31 weeks). In addition, the proportion of wounds healed were significantly higher for BLCC by 12 weeks (42% vs. 24%) and 24 weeks (65% vs. 41%) (p = 0.0002). Treatment with BLCC increased the probability of healing by 97% compared with CCSA (hazard ratio = 1.97 [95% confidence interval 1.39-2.79], p = 0.0002). Innovation: This is the first real-world comparative effectiveness analysis to evaluate BLCC and CCSA for the treatment of VLUs. Conclusion: Treatment with a bioengineered cellular technology significantly improved the incidence and speed of wound closure compared with a CCSA.

Inpatient and Outpatient Wound Treatment Recommendations: Assessing Use of Negative Pressure Wound Therapy Systems or Oxidized Regenerated Cellulose (ORC)/ Collagen/Silver-ORC Dressings.

The increase in wound prevalence means more patients with wounds are being transferred through care settings than ever before. Although the goals of therapy may be the same in both settings, wound care therapies and dressings differ in availability and appropriateness for each setting. Negative pressure wound therapy (NPWT) modalities and oxidized regenerated cellulose (ORC)/collagen (C)/silver-ORC dressings are available in both inpatient and outpatient care settings, but (to-date) lack comprehensive information regarding best practices in transitioning use of these therapies between various care settings. A panel meeting was convened to provide literature- and experience-based recommendations in transitioning wound care patients between various care settings. The use of NPWT with instillation and dwell time was recommended in wounds contaminated with debris and/or infectious materials or heavy exudate. In addition, ORC/C/silver-ORC dressing application was recommended for surface bleeding and for placement into explored areas of undermining to help promote development of granulation tissue. When transitioning a patient from inpatient to outpatient care, overall health, access to services, severity and complexity of the wound, and equipment availability should be taken into consideration. Treatment modalities to bridge the gap during care transition should be used to help maintain continuous care. For outpatient care, NPWT use was recommended for removal of infectious materials and exudate management. The ORC/C/silver-ORC dressings also may be used to help manage exudate and promote granulation tissue development and moist wound healing. In addition, practice challenges and potential solutions for patient adherence, interrupted care during patient transition, and troubleshooting after hours and weekend device alarms were discussed.

Management of Chronic Wounds: Diagnosis, Preparation, Treatment, and Follow-up.

Management of chronic wounds remains challenging in terms of prevalence and complexity. Considerable progress has been made in understanding the science of wound healing during the past decade, sparking volumes of publications and the development of hundreds of dressing and therapy options. There is a need for a simpli ed overview of evidence-based criteria to assist in the accurate diagnosis and appropriate management of chronic wounds in all care settings. An expert panel of 11 wound healing specialists experienced in various care settings convened to discuss best practices and recommended guidelines for managing major chronic wound types. Prior to the meeting, panel members reviewed 8 preselected peer-reviewed articles and 1 white paper containing treatment algorithms for all major chronic wound types. During the meeting, each panelist presented current evidence-based guidelines regarding a specific chronic wound type and case studies to illustrate concepts in the guidelines. This publication is a result of the panel discussion and presents an overview of literature- and experience- based criteria to help guide chronic wound diagnosis, assessment, treatment, and follow-up. A cycle of steps is presented as a framework to guide holistic care for all patients with chronic wounds, including de- hisced surgical wounds, diabetic foot ulcers, venous leg ulcers, arterial insu ciency ulcers, and pressure ulcers/injuries. Emphasis is placed on criteria to assist accurate diagnosis and dressing/therapy selection, holistic elements of patient and wound bed preparation, interventions to achieve patient adherence to a care plan, and follow-up to help prevent wound recurrence.

Wound Care Centers: Critical Thinking and Treatment Strategies for Wounds

Many wound care centers (WCCs) provide a specialized level of care using various wound care therapies and are managed by quali ed healthcare professionals (QHPs) from di erent specialty backgrounds such as family medicine, podiatry, and plastic surgery. However, these QHPs are sometimes challenged by reimbursement issues, limited therapy and dressing options, reduced access to multidisciplinary team members, and cost-driven factors unique to WCCs. To help address these issues, a meeting was convened by an expert panel of WCC physicians to discuss best practices for treating complex patients in a WCC. This publication presents an overview of WCC chal- lenges, describes a holistic approach to treating WCC patients, and provides clinical guidance on the decision-mak- ing process for selecting optimal treatment plans for the WCC patient. Clinical cases of atypical, surgical and chronic wounds seen in a WCC are also presented.

Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft.

UNLABELLED: While randomized controlled trials (RCTs) are designed to evaluate efficacy and/or safety under controlled conditions, use of strict inclusion/ exclusion criteria are noted to exclude more than 50% of wound populations. Applicability of RCT outcomes to performance expectations in real-world wound populations raises questions about generalizing their results. The primary aim of this decellularized, dehydrated human amniotic membrane (DDHAM) Use Registry Study was to gain experience and observe outcomes with use of a DDHAM in uninfected, full-thickness, or partial-thickness wounds that, in the investigators' opinions, would benefit from such treatment. METHODS: Investigators were instructed to provide usual care regarding visit and application frequencies, concomitant therapies, and change in wound-care regimens. The only exclusions were patients with actively infected wounds or known hypersensitivity to DDHAM. Fifteen sites with practicing wound care clinicians of various specialties participated in this review, enrolling chronic wounds including venous, diabetic, pressure, collagen vascular, and arterial ulcers-all of various severities, durations, sizes, and previous treatments. Twenty-eight ulcers studied had failed 32 previous treatments with advanced biologic therapies. A total of 244 wounds were observed in this study, however, this review is limited to the 179 chronic wounds in 165 patients that were enrolled at 15 of the 19 participating centers. The 4 centers that enrolled acute wounds only were excluded. RESULTS: Results from the analysis of this very heterogeneous population demonstrated that during the usual course of an average of 8 weeks of wound management, patients experienced factors that significantly affected wound closure. These factors included wound infections, noncompliance with prescribed treatments (eg, compression, off-loading, and wound care), re-injury of the wound, and systemic comorbidities. Nearly 50% of chronic wounds (including those that failed previous therapy with advanced biologics) with an average baseline area of 3.1 cm2 achieved complete closure within a median of 6.3 weeks without product-related adverse experiences. CONCLUSION: Despite the challenges of uncontrolled factors that affect healing, this registry study demonstrated the safety and clinical benefit of DDHAM to support wound closure across a variety of chronic wound types and patient conditions in real-world environments.

DOMINATE Wounds.

Chronic wounds are a significant health problem worldwide. Often they are initially managed with various focal treatments until a specialist becomes involved, sometimes weeks or months after treatment has begun. Even at the specialist level, practices and guidelines are inconsistent due to a lack of high-level evidence. A disease management system for chronic wounds that is simple, practical, and adoptable by a variety of wound care practitioners is needed. Such a system would guide wound care providers to address the critical aspects of wound care in a prioritized, systematic sequence, leading to faster healing of simple wounds, and timely advancement to more complex therapies for wounds that require such treatment. This paper describes an empirically developed wound care management system that has been successfully implemented and provides evidence-based rationale for each of its components. Relatively simple and practical, this system organizes an approach to any type of wound, routine or complex.