Wounds and Injuries

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy.

Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.

One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.

Insertion of suction drain(s) following mastectomy

Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery.

Adaptive skin sutures.

Zoltan Matrai, M.D.

Laszlo Toth, M.D., Ph.D.

Miklos Kasler, M.D., Ph.D., D.Sc., Prof.

Laszlo Toth, M.D., Ph.D., Prof.

Ferenc Renyi Vamos, M.D., Ph.D.

Akos Savolt, M.D.

Emil Farkas, M.D.

Ildiko Horti, M.D.

The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study

Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study

By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented.

Assessment of analgesic consumption to achieve adequate pain relief for each patient. Pain relief is carried out according to institutional protocol and includes: diclofenac sodium, diclofenac sodium + orphenadrine, nalbuphine, metamizole sodium, paracetamole, tramadole.

Using EORTC QoL BR23, weekly for 4 weeks following surgery.

Assessing shoulder motion on the 1st postoperative day, then weekly for 4 weeks.

Abduction 1: 0°- 45° Abduction 2: 45° - 90° Abduction 3: 90° - 135° Abduction 4: 135° - 180°

Suction drain, suction flask, syringes, number of patient-doctor consultations

National Institute of Oncology, Hungary

principal investigator

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

Nervous System Diseases

Rare Diseases

Pain

Pain, Procedural

Breakthrough Pain

Neurologic Manifestations

Oculocerebral Syndrome With Hypopigmentation

Mobilization

Positioning

Personal Hygiene Care

Bladder catheterization

Wound care

Subcutaneous drugs administration

Giuseppe Casale, Medicine

This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study

Self reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain).

Antea Foundation

Behaviors and Mental Disorders

Quality of Life

malignant fungating wounds care regimen based on the evidences, expert consultation, pre-experiment and final determination

1) Preliminary construction of regimen: The researchers summarized the literatures and guidelines about malignant fungating wounds care, and then formed a preliminary draft of the regimen.2) Expert consultation: Experts in malignant fungating wound care, breast cancer and rehabilitation were consulted by email, and the researchers revised the protocol according to the experts' comments, and the final draft was determined after multiple rounds of consultation with experts. 3) Pre-experiment: The researchers investigated the enrolled patients to assess the feasibility of the protocol, and adjusted the content based on the feedback.4) Final Determining: including health records establishment, the intervention time, implementers, location, method and frequency. A wound care team was formed, interventions were carried out in terms of somatic care, wound home care, psychological support, and rehabilitation guidance, and the enrolled patients would be regularly followed by the researchers.

malignant fungating wounds care regimen

liangzhi Qiu, M.D.

Liangzhi Qiu, M.D.

Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life.

Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus, and there is an interrelationship between the symptoms. The symptoms presented by patients have certain individual differences and vary with the stage of treatment and treatment effect, which bring different degrees of distress to patients and their families and seriously affect patients' prognosis and quality of life. It is found that wound symptoms such as malodor are significantly negatively correlated with the quality of life of patients with malignant fungating wounds. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. With the continuous improvement of cancer treatment level, patients' quality of life is more representative of cure and recovery than survival to some extent. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will take the symptom management theory as the guide, start from the actual needs of patients and combine with the actual clinical situation to construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life and make their lives dignified and meaningful.

Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients

Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory

Patients were counted to self-report the number and severity of wound bleeding in the recent 1-week period, the severity of wound bleeding was reported by the patient using a scale of 1\~10, and higher scores mean a more severe and frequent wound bleeding reported by patients in the last week.

described by "healing, improvement, maintenance, deterioration", where "wound healing" refers to 100% epithelialization of the wound, "wound improvement" refers to reduction of the wound area, "wound maintenance" refers to no change in the wound area, and "wound deterioration" refers to an increase in the wound area.

measured using the scale named "Toronto Symptom Assessment System for Wound(TSAS-W)"; the minimum and maximum values are 0 and 100 respectively, and higher scores mean a worse wound symptom reported by patients.

measured using the scale named "Quality of Life instruments for Cancer Patients-Breast Cancer(QLICP-BR)". There are 37 items, and 5\~10 and 27\~32 are positive entries, and the rest are reverse entries. Using Likert 5-level scoring method, the total score is 36\~180 points. The higher the total score, the better the quality of life. Only 35 items were used in this study.

measured using the scale named "Social Support Rate Scale(SSRS)".The scale includes 10 items and 3 dimensions, with a total score of 11-59. The higher the total score, the better the social support.

measured using the scale named "Self-rating Anxiety Scale(SAS)". SAS scale includes 20 items. If it is a positive scoring question, it will be rated as rough score 1, 2, 3 and 4 in turn; Reverse scoring questions (those with \* sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SAS standard deviation is 50 points, of which 50 \~ 59 points are mild anxiety, 60 \~ 69 points are moderate anxiety, and more than 70 points are severe anxiety.

measured using the scale named "Self-rating Depression Scale(SDS)". SDS scale includes 20 items and 10 positive scoring questions, which are rated as rough scores of 1, 2, 3 and 4 in turn; 10 reverse scoring questions (those with \* sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SDS standard score is 53 points, of which 53-62 points are mild depression, 63-72 points are moderate depression, and more than 73 points are severe depression.

measured using the scale named "Stigma Scale for Chronic Illness 8-item version(SSCI-8items)". The scale is developed on the basis of the 24 item stigma scale for chronic illness (SSCI), with a total of 8 items, of which 3 items are from internal shame, 5 items are from external shame, and all items are positive. The five options of the scale are: No, little, sometimes, often, always, and assigned 1, 2, 3, 4, and 5 points respectively, with a total score of 8 to 40 points. The higher the score, the higher the level of shame.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
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
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment	NCT02437929	Breakthrough Pa... Pain Due to Cer... Pain Cancer Terminal Diseas...	Mobilization Positioning Personal Hygien... Bladder cathete... Wound care Subcutaneous dr...	18 Years -	Antea Foundation
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment	NCT02437929	Breakthrough Pa... Pain Due to Cer... Pain Cancer Terminal Diseas...	Mobilization Positioning Personal Hygien... Bladder cathete... Wound care Subcutaneous dr...	18 Years -	Antea Foundation
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients	NCT05457309	Malignant Funga...	malignant funga...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment	NCT02437929	Breakthrough Pa... Pain Due to Cer... Pain Cancer Terminal Diseas...	Mobilization Positioning Personal Hygien... Bladder cathete... Wound care Subcutaneous dr...	18 Years -	Antea Foundation

Spots Global Cancer Trial Database for wound care

Every month we try and update this database with for wound care 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 wound care

Every month we try and update this database with for wound care 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 wound care 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.