Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Head and Neck Neoplasms

Ulcer

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Bacterial Agents

Carboxymethylcellulose Sodium

Laxatives

Cathartics

Silver, in its common ionic (active) form (Ag+), is particularly attractive as an antibacterial agent because it can be readily incorporated into dressing materials. Silver-dressing are wound products designed to control infection and provide a wound environment conducive to management exudates, pain, and malodour.

Experimental group are accepted primary dressing the AQUACEL Ag. control group are provided with the AQUACEL on the wound surface. Wound specialist or primary nurses undertaking wound care are informed by inclusion criteria that the treatment shall be adhered to during the two-week study period.All wounds are cleansed with sterile saline prior to assessment and dressing application.The sterile, non-woven sodium carboxymethylcellulose primary AQUACEL Ag with 1.2% ionic silver.Each secondary dressing is covered a sterile gauze.Dressings are changed between daily assessments when judged necessary.Patients attended the wound ward weekly for treatment evaluation. All participating clinics used the same wound management guidelines and data collection forms.

silver-releasing dressings

We-Yu Hu

Background. Malignant fungating wounds(MFW) are caused by cancerous cells invading skin tissue, which exhibit increased bacterial burdens that not only result in a negative physical impact (odour, exudates, pain, and infection) on patients, impairing their quality of life, but they also increase treatment costs. A systematic review of the effectiveness of that the silver-releasing dressing in the management of infected chronic wounds can help enhance control of wound bed infection and inflammation, tissue management, moisture balance, and protect wound edge. However, few studies have examined the effects on people with MFW.

Hypothses In this study that the hypothesized that cancer patients in the ionic silver dressing group will perception higher quality of life compared to patients in the control group who receive non-ionic silver dressing. In addition, we hypothesized that cancer patients who also receive ionic silver dressing will have lower level of symptom distress at end of study compared to patients in the control group receive non-ionic silver dressing care.

Introduction. At the beginning of the 21st century, cancer is increasing in the aging population and patients often have a greater life expectancy than they did 40 years ago (Payne et al 2004). As people age, and the incidence of cancer increases, it is essential to push the frontiers of oncology care to meet the symptom management needs of these patients. For many, cancer has become a slowly progressive, chronic disease - a change that brings with it particular challenges for oncology nurses (Hoskin and Makin 1998). A systematic review of the effectiveness of that the silver-releasing dressing in the management of infected chronic wounds can help enhance control of wound bed infection and inflammation, tissue management, moisture balance, and protect wound edge. This study is designed to assess the effects of ionic silver dressing (AQUACEL Ag) in head and neck patients with malignant fungating wound (MFW) on the quality of life, symptom distress and wound bed changed of patients with MFW

Definition of MFW. Malignant Fungating wounds arise as a result of infiltration of the structures of the skin by malignant cells. These cells may arise from primary skin cancer, an underlying malignant tumor or through metastasis spread from a distant malignant tumor(Punder, 1998).A fungating cancer is a primary or secondary malignant growth in the skin which has ulcerated and results in pain, exudates, bleeding, infection and malodour(Twycross, 1995) .A malignant tumor will invade and destroy adjacent tissues and can spread to other tissues with in cells that break off and travel in the blood or lymph system. It can develop its own blood supply, sometime outgrowing it and causing the tumor to become necrotic in the middle(Mera, 1997).Dealey(1994) states that, as the tumor extends, capillaries rupture, leading to epithelium results in ulceration through the skin, and lesions presents as a fungating, foul-smelling mass(Daeley, 1994).Fungating malignant wounds are caused by the infiltration of the skin and its supporting blood and lymph vessels by a local tumor or as a result of metastasis growth from the primary tumor. Unless the malignant cells are checked by single or combination cancer treatments the fungation extends with the potential for causing massive damage at the wound site through a combination of proliferate growth, loss of vascularity and ulceration(Mortimer, 1998) .A fungating wound is defined as a cancerous lesion involving the skin, which is open and may be draining. The lesion may be result of a primary cancer or metastasis to the skin from a local tumor or from a tumor in a distant site. It may take the form of a cavity, an open area on the surface of the skin, skin nodules, or a nodular growth extending from the surface of the skin(British Columbia Cancer Agency, 2001) .As the malignant cells multiply in the skin they form a tumour that enlarges causing disruption of skin capillaries and lymph vessels, eventually leading to tissues Hypoxia and subsequent skin necrosis.

Infection control of MFW. All chronic wounds contain bacteria. Kingsley(2003) state that the change in numbers of bacteria and the body's response as a continuum, rating from contamination to infection(Kingsley, 2003). Contamination is mean that the bacteria present on the wound surface but are not proliferating and have no clinic effect; colonised imply bacteria have proliferated, but there is no host reaction; critical colonisation occurs where the body's local host response starts to be initiated, but there are no systemic sign of infection; Infection is point in time when the bacteria have multiplying and invaded deeper tissues, healing is impaired and produced a systemic host reaction(Jacqui. Fletcher, 2005; Verdu Soriano , Rueda Lopez, Martinez Cuervo, \& Soldevilla Agreda 2004) .

Clinical recognition of these rating stages is not easy because there are no clear descriptors. However, Soriano et al (2004) defined classification according to the number of bacteria present in the wound bed: Contamination-≦103 colony-forming unit (CFUs) per gram of tissues; colonised -≦104 CFUs ; Infection -≧105 CFUs. Cutting and White noted several aspects of wound infection such as: serous drainage with concurrent inflammation, discoloured granulation tissue, pocketing at the wound base, unexpected pain , foul odour, increase in exudates, exudates that becomes purulent instead of serous, and wound breakdown(White \& Cutting, 2006).

In the MFW, the presence of hypoxic necrotic tissues within the wound provides an excellent medium for growth of aerobic and anaerobic bacteria(J. Clark, 2002). Anaerobic and aerobic bacteria thrive in these conditions, giving rise to excessive malodour wound exudates(Haisfield-Wolfe \& Rund 1997). Lo et al (2006) survey of seventy cancer patients with MFW in Taiwan, the study found that the 60.3% wound bed presented necrotic tissue ; malodour was present in 50% of patients ; 81.4% shows moderate to large exudates and 71.4% reported purulent(Lo, 2006). According above the data, infection has emerged as a major health problem during the patient suffers MFW.

Ionic silver dressing. Silver, in its common ionic (active) form (Ag+), is particularly attractive as an antibacterial agent because it can be readily incorporated into dressing materials. When the materials contact an aqueous environment, the silver complex contained in them is dissociated (Ovington 2004, White \& Cutting 2006). The mechanism of action for Ag+ is that it binds to bacterial cell DNA, and enzymes, and proteins in the cell wall. Once the silver cation attaches to these sites, it alters their structure, resulting in structural and functional changes in the bacterial cell (Ovington 2004).It is suggested by numerous authors that silver dressings should be utilized when critical colonization within a wound occurs (Ovington 2004, White \& Cutting 2006, Lo et al 2008). Therefore, this study research questions is (1)What are the effects of ionic silver dressing (AQUACEL Ag)in head and neck patients with malignant fungating wound, as compared to hydrofiber dressing(AQUACEL), on the individual perception subjective quality of life?(2) What are the effects of ionic silver dressing (AQUACEL Ag) in head and neck patients with malignant fungating wound, as compared to hydrofiber dressing (AQUACEL) alone, on the symptom distress and wound bed changed of patients receiving ionic silver dressing (AQUACEL Ag) for cancer patients?

The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound

National Taiwan University Hospital

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Cancer Pain

Chronic Pain

Pain

Skin Ulcer

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

Morphine

Analgesics, Opioid

Narcotics

topical morphine

Pesach Shvartzman, Professor

Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified.

We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine.

Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.

Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

Israel Cancer Association

Soroka University Medical Center

Head-Department of Family Medicine

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Digestive System Diseases

Heart and Blood Diseases

Immune System Diseases

Infections

Ear, Nose, and Throat Diseases

Diabetes Mellitus

Anxiety Disorders

Depressive Disorder

Dementia

Kidney Diseases

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Osteoporosis

Thyroid Diseases

Hyperlipoproteinemias

Hyperlipidemias

Crohn Disease

Colitis

Colitis, Ulcerative

Depression

Heart Failure

Asthma

Stroke

Hypertension

Gastroesophageal Reflux

Ischemia

Arthritis

Irritable Bowel Syndrome

Lung Diseases

Arthritis, Rheumatoid

Hepatitis A

Hepatitis

Acquired Immunodeficiency Syndrome

HIV Infections

Hepatitis, Chronic

Musculoskeletal Pain

Bronchitis

Ischemic Attack, Transient

Bronchitis, Chronic

Diverticulum

Diverticular Diseases

Vascular Diseases

Gastrointestinal Diseases

Joint Diseases

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Dyslipidemias

Lipid Metabolism Disorders

Muscular Diseases

Communicable Diseases

Respiratory Tract Infections

Bronchial Diseases

Brain Ischemia

Cerebrovascular Disorders

Pathological Conditions, Anatomical

Familial Alzheimer Disease

Intervention group (n = 163) Intervention: Participates in DIMAC02 Program

Health Administrative Data Group (n = 1630) Number of matched data controls. Not taking part in intervention.

Integrated Approach For Chronic Diseases (DIMAC02) is an integrated approach for chronic disease prevention and management services that aims to improve and coordinate different regional initiatives in 11 Family Medicine Groups(FMG) related to : Self-management, Case management, Patient-centred care for persons with multimorbidity, Motivational approach, Interprofessional collaboration. DIMAC 02 specific objectives are: 1) To make available, in FMG's, an interdisciplinary educational intervention for prevention and management of chronic diseases for patients with low and high risk for complication. 2) To Increase the flow of communications between FMG and hospital facilities to improve continuity of care.

DIMAC02

Martin Fortin, MD, M.Sc

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

A recent systematic review on the prevalence of Multimorbidity (MM) recommended a count of 3+ chronic diseases, with no focus on any single chronic disease in particular. This definition identifies a more vulnerable population with higher needs, lower income or poverty, poorer outcomes and challenging processes of care. It includes people with a wide array of complexity from the uncomplicated course of minimally interacting chronic diseases to the highly complex MM patients. MM is not only important due to the burden on patients, but because it accounts for high utilization. The definition represents a continuum of vulnerability in which there are many opportunities for prevention and management. Despite the high prevalence of MM, most research and health care is still based on a single disease paradigm which may not be appropriate as 45% of primary care patients have MM. A recent Cochrane systematic review on the impact of interventions for patients with MM has identified a paucity of studies internationally with mixed results, thus paving the way for the work of this Team. The most promising intervention, to date, was enhanced teamwork in a multifaceted intervention involving multiple professionals.

Patient-Centred Partnerships between Patients and Providers: The definition of patient-centred partnerships is derived from Canadian policy reports: "collaboration between informed, respected patients and a healthcare team." There is an internationally accepted comprehensive operational definition with four components which will guide many aspects of the proposed research program: first, exploring the patients' diseases and the illness experience; second, understanding the whole person in context; third, finding common ground; and fourth, enhancing the patient-provider relationship. There is empirical evidence for the impact of patient-centred partnerships on better patient outcomes and lower costs. Systematic reviews of interventions indicated promising results for feasible practice-based interventions targeting both providers and patients.

Canadian policy reports defined this second facet of patient-centredness, as "seamless coordination and integration of care." Transitions requiring coordination are a key feature of care for patients with MM. Coordination has been shown to positively impact: symptom relief; social functioning; hospital re-admission and related costs. Papers reviewed by this Team identified the most promising type of intervention to be structured delivery system re-design.

STUDY #2.1 Qualitative Evaluation of the aligned Programs Purpose: The study will: assess how the transformed program performs; distinguish between components of the interventions; and identify contextual factors that may have influenced the content and effectiveness of the intervention. It will also examine the local barriers and facilitators as well as the transitions and coordination of care.

Methods and design: The Team will conduct a qualitative evaluation of the transformed programs to explain how various contexts influence observed effects \[1\] including the context of the health care systems in each province. A recent example of this research approach in Canada is Best et al, 2012 \[2\]. Data will be obtained from interviews and written documents. In-depth interviews will be conducted among the four categories of stakeholders. This will include: a) decision-makers (n = 10); b) primary care physicians (n = 10); c) professionals doing the interventions (n = 10); and a d) purposive sample of patients with multimorbidity (n = 10) and their informal caregivers (n=10) \[51\]. The number of interviews are estimates and will be guided by the saturation of data \[3\].

Data collection: In-depth interviews, lasting 30 to 60 minutes will ensure complete and detailed participation. The data collection will be held during the second year of the transformed program. The interview guides will examine how the context variables influence the effects and the elements that could potentially inform the development of future interventions. All interviews will be audiotaped and transcribed verbatim. Additionally, written documents will be collected (program team meeting summaries, a sample of 10 medical records or research records at each participating site, a checklist describing the fidelity of the intervention, all documents produced specifically for the intervention) to provide an in-depth understanding of the various contexts in which the interventions occurred.

Data analysis: The data will be analyzed using an iterative and interpretative approach \[4\]. The data from all participants will be examined through both independent and team analysis occurring in a concurrent manner to build and develop on the emerging themes. A coding template will be developed and edited as new themes emerge while others are reclassified or discarded. A data management software will be used to organize the coded data and identify exemplar quotes reflecting the central themes. All written documents will undergo a content analysis. The final step of the analysis will be the triangulation of the synthesis of the themes from the stakeholder participants and the content analysis of the documents.\[3-4\] STUDY #2.2: Evaluation of effects of the aligned Programs Setting: The same consenting participating sites as described in study 2.1. The methods presented below are for one setting and will be duplicated in the second setting. Patients are referred to receive the services of these programs by their providers. The intervention the investigators are testing here is the aligned programs. Patients referred to these programs are new patients and have never been exposed to the intervention. In addition to the main reason for referral to the program, the referral form will also include eligibility details for the evaluation, including diagnoses.

Patient sample: Patients recruited for the study will be cognitively intact and literate and aged between 18 and 80 years of age. The upper limit of 80 years is to avoid recruiting patients at risk of being institutionalized or dependent during the follow-up. Patients will present at least three chronic conditions.

Methods and Design: Patients agreeing to participate will complete questionnaires at baseline (T1) collecting the sociodemographic data and baseline measures, which will be used to document equivalence between groups (groups are defined below). Effectiveness of the aligned program will be assessed using three strategies.

1. To measure short-term effects (4 months), a randomized controlled trial (RCT) design with a delayed intervention will be used \[5\]. Eligible patients will be randomized after consent to receive either the intervention within a short period of time (Group A) or 4 months later (Group B); self-reported mailed questionnaires will be completed at baseline (T1) for all patient participants, 4 months after the end of the intervention for group A (T2) and 4 months after baseline for control group B (T2). This will constitute the short-term measure of effectiveness of the intervention. Group B will then receive the intervention.
2. To measure the mid-term effects (one year) on patient-reported outcomes, a before and after study is proposed combining groups A and B together. The patients will complete the same questionnaire 12 months after the end of the intervention (T3).
3. To measure mid-term (T3) and long-term effects (T4 after 2 years) on health services utilization and cost, all patients (groups A and B) will provide consent to give access to their health administrative (HA) data. At baseline, a control Group C will be constituted using anonymized HA data. Patients will be matched for gender, age, region and main three diagnoses. The Team will build algorithms for matching every set of controls. Groups A and B together will be compared to this propensity matched control group C in a before-after study using administrative (HA) data.

Variables and outcome measures: The variables fall into 5 categories: sociodemographic; PC context; main co-variables of interest; primary outcomes; secondary outcomes. Socio-demographic characteristics include gender, age, education, family income, marital status, occupation, housing and number of persons living under the same roof. Context variables refer to type of PC organization in which the intervention occurs (Family Medicine Group). The three main co-variables of interest are the Team's three innovations: self-reported multimorbidity (measured by the Disease Burden Morbidity Assessment \[6\]; patient-centred partnership (Patient Perception of Patient-Centredness Scale \[7-9\]); and Patient centered coordination (the Patient Perceptions of Transitions in care, adapted by the investigators from Coleman \[10\]). The two primary outcome measures are the Health Education Impact Questionnaire (HeiQ) that provides a broad profile of the potential impacts of patient education interventions \[11\] and the level of perceived disease-management self-efficacy using the 6-item Self-Efficacy for Managing Chronic Disease (SEM-CD) \[12\]. Secondary patient perceived outcomes will be the VR-12 as a measure of health status and the "EuroQoL group" instrument called "EQ5D" as a measure of Quality of Life \[13\]. The Kessler psychological distress scale K-6 will measure psychological distress \[14\]. The investigators will also use a questionnaire on health behaviors \[15\]. Finally, HA data will also be used as secondary outcomes to compare health care utilization and cost before and after the intervention. HA data will include emergency department visits, avoidable hospital admissions, readmissions, time to first primary care visit after emergency department visit and continuity of care.

Data analysis: Investigators will first describe participants' baseline characteristics in each group and compare among groups. To evaluate short-term effect, Groups A and B will be compared on T2 scores with an analysis of co-variance (ANCOVA) adjusted for T1 scores \[16\]. To document mid-term effects, a before and after measures analysis of variance will be used to study the evolution of continuous variables collected 3 times \[17\]. Sub-analyses by gender will be performed. Health system costs in intervention and control groups will be evaluated by using amounts paid to providers based on provincial fee schedules and cost-weighted utilization of institutions including hospitals and long-term care. Utilization records obtained from HA data will be multiplied by applicable cost weights \[18\] The methods employed will model the individual patient-level costs incurred in the health system, using methods developed for costing using administrative data\[19\]. Incremental resources in the intervention group will be identified and costed using applicable time/resource inputs and relevant wage rates following guidelines for economic evaluation in health interventions \[20\].

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

Health Education Impact Questionnaire (HeiQ). Score: Reliable improvement

Multimorbidity/Chronic Disease (MM-21): Score: number of Chronic diseases

Health Status (VR-12): Score: Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Psychological Well-being (Kessler 6 Scale).Score: mean

Lifestyle/Health Behaviours Questionnaire. Score: mean

Patient Perception of Transitions of Care. Score: Mean

Self-Efficacy for Managing Chronic Disease Scale (SEM-CD). Score: mean

Patient Perception of Patient-Centredness (PPPC). Score: Mean

Canadian Institutes of Health Research (CIHR)

Western University, Canada

Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean

Université de Sherbrooke

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound	NCT00813631	Head and Neck N... Head and Neck C... Wounds Ulcer	silver-releasin...	18 Years -	National Taiwan University Hospital
Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain	NCT00306020	Ulcer Wounds and Inju...	topical morphin...	18 Years - 75 Years	Soroka University Medical Center
Patient-Centred Innovations for Persons With Multimorbidity - Quebec	NCT02789800	Hypertension Depression Anxiety Musculoskeletal... Arthritis Rheumatoid Arth... Osteoporosis Chronic Obstruc... Asthma Chronic Bronchi... Cardiovascular ... Heart Failure Stroke Transient Ische... Ulcer Gastroesophagea... Irritable Bowel Crohn's Disease Ulcerative Coli... Diverticulosis Chronic Hepatit... Diabetes Thyroid Disorde... Cancer Kidney Disease Urinary Tract P... Dementia Alzheimer's Dis... Hyperlipidemia HIV	DIMAC02	18 Years - 80 Years	Université de Sherbrooke

Spots Global Cancer Trial Database for ulcer

Every month we try and update this database with for ulcer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ulcer

Every month we try and update this database with for ulcer cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ulcer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.