Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Head and Neck Neoplasms

Cancer Pain

Pain

Breast Neoplasms

Neurologic Manifestations

Breast Diseases

Skin Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Lidocaine

Morphine

Analgesics, Opioid

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Narcotics

For the preparation of the gel formulated for the intervention, the proportion of an ampoule of dimorf® (morphine sulfate) in the injectable presentation of 10mg/ml will be used. Morphine sulfate is a strong, systemic opioid analgesic used for the relief of severe pain.

For the base of the compound, Curatec Hidrogel with Alginate® will be used. A transparent and viscous hydrogel, which provides a moist environment, preventing the dressing from adhering to the skin, preventing additional injuries generated by difficulty removing the dressing.

Morphine Sulfate

The control group will receive lidocaine® in gel (2% sterile jelly lidocaine hydrochloride) alone. Because it is a homogeneous, transparent gel, free of lumps and impurities, it has similar characteristics to the hydrogel (Curatec Hidrogel with Alginate®) used in the preparation of morphine gel, guaranteeing the blinding of the study.

Lidocaine Hcl 2% Jelly

Daianny A de Oliveira da Cunha, MSc.

The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is:

• Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire where they report a note for pain at the site of the malignant wound and then the dressing will be performed by a nurse from the research team. The patient and the nurse do not know which product is being used. At the end of the dressing, the patient answers a new questionnaire. This process will be carried out for 3 days.

The researchers will compare the intervention group (morphine gel) and the control group (lidocaine gel) and verify if there is a difference in pain reduction between the two products.

Potential participants will be all patients with malignant wounds in the head and neck or breast region who meet the inclusion and exclusion criteria, forming the study population.

After signing the free and informed consent form, the intervention group will receive topical morphine based on hydrogel in the formulation of 10mg of morphine sulfate - intravenous solution (1 ml) with 8g of hydrogel and the control group will receive lidocaine in gel.

To ensure the quality and accuracy of the data, in addition to the safety of the research participants, face-to-face monitoring visits will be carried out by the team from the Representative Area of Clinical Research (ARPC)/INCA throughout the execution of this protocol.

After signing the TCLE by the patient and researcher, the completion of the clinical form will begin. The pharmacist of the research team responsible for the randomization will be contacted to inform the inclusion of the patient in the study. The research team doctor will be responsible for prescribing the medication to be used, be it morphine or lidocaine gel, with a view to release by the hospital pharmacy.

Both morphine gel and lidocaine gel will be prepared in a flow hood suitable for handling the medications.

Adverse events will be reported, using medical terminology, in the source document and in the eCRF (electronic case report form). Upon identification of a reaction, the participant will be evaluated by the research team physician. All measures required for the treatment of the adverse event will be recorded in the source document.

Randomization and allocation will be performed using Research Electronic Data Capture (REDCap) software in a form that will only be viewed by non-blind members of the pharmacy team, responsible for handling the products and sending them to the team nurse who will be responsible for wound dressing evil.

The data collection forms (eCRF) will be customized in the REDCap software by the representative research area (ARPC) data management team. The data will be entered into the eCRFs according to the standard operating procedures of the Division of Clinical Research-INCA. The data will be exported to the R software by API (Application Programming Interface) where the statistical analyzes will be performed.

The sample size of each group was determined using the G\*Power application (version 3.1.9.4), using the Wilcoxon and Mann-Whitney nonparametric test approach. The calculation suggests a minimum sample size of 53 patients per group.

In the first part of the analysis, a descriptive analysis of the sample profile and comparison of the baseline variables of the control and intervention groups will be performed. The second part will evaluate the effect of the treatments in the control and intervention groups, analyzing the significance of the observed differences and the size of the treatment effect.

For qualitative variables, the significance of the association between two variables, or the difference between the distribution of the proportions of the two groups, will be investigated using the chi-square test and, when it proves to be inconclusive, Fisher's exact test will be used.

The odds ratio (OR) will be the measure used to express some risk of a qualitative outcome when comparing the occurrence of the outcome in the groups.

For quantitative variables, the normality of distributions will be verified by the Kolmogorov-Smirnov and Shapiro-Wilk tests. If the variable of interest has a normal distribution in both groups, the comparison will be made using the student's t-test; if at least one of the groups does not present normal distribution, or if the variable to be compared is an ordinal scale, such as the pain scale, the comparison of the two groups will be performed using the Mann-Whitney test.

Two repeated measures in different evaluations will be compared by the paired Student's t-test, if the two measures present normal distribution, or by the Wilcoxon signed rank test, if at least one of the measures does not present normal distribution or if it is a scale measure ordinal.

More than two repeated measures will be compared by ANOVA for repeated measures, in the case of normality for all measures, or by the Friedman test, if at least one of the measures does not present normal distribution, or if it is an ordinal scale measure.

Classifications or qualitative factors observed repeatedly at different times will be compared by McNemmar test.

The effect of the received intervention on the pain score will be evaluated by the Glass effect size measure.

Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds

Effectiveness of Topical Morphine Use in Patients With Painful Neoplastic Wounds in the Breast and Head and Neck: Double Blind Randomized Clinical Trial - MorphineGEL

The scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible

Difference in the means of pain assessed by the numeric pain assessment scale before and after the intervention.

General comfort questionnaire with scores ranging from 48-192, where 48 reports the worst comfort measure and 192 the highest comfort level reported by the patient.

Instituto Nacional de Cancer, Brazil

Principal Investigator

Rare Diseases

Chronic Pain

Ulcer

Skin Ulcer

Chronic Graft Versus Host Disease

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

Anti-Infective Agents

Pharmaceutical Solutions

Metronidazole

Polihexanide

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Disinfectants

Polihexanide 2%

Metronidazole 0.8%

For odor control malignant wounds (MW), use is 0.8% metronidazole solution - second recommendation scientific and clinical practice. But no this formulation available in Brazil , and its application to nursing steeps metronidazole tablets , diluted in saline and applied to the bed of (MW) . Thus , it is used off label for metronidazole ( tablets orally applied via " topical " - but it is not intact skin or mucosa ) , nursing and eventually manipulate the solution at bedside , and by law this power is pharmacist bedside and can not be taken .

Family antiseptic chlorhexidine was developed with the purpose of use in infected wounds called polihexanide ( PHMB ) . In Brazil is now available for hospital and home care ( 0.2 % Aquasept ® ) use. Evidence reported positive results in controlling infection of chronic wounds such as pressure ulcers . Although not tested its efficacy in odor control. Thus the study aims to compare metronidazole solution 0.8 % versus 0.2 % PHMB in odor control , where , if the results are favorable to PHMB we have a treatment option in odor control with ready to use formulation and easy access . Evaluate and compare the effectiveness of metronidazole solution 0.8% and polihexanide solution (PHMB) in odor control in MW. Aims: Evaluate and compare the time needed for odor control (reduction in days), using metronidazole and PHMB in MW (primary endpoint); Evaluate and compare the perceptions of patients, nurses and researcher on the odor MW, using metronidazole and PHMB in the MW; Evaluate and compare the pain reported by patients during dressing changes, using metronidazole and PHMB in the MW; Evaluate and compare the quality of life of patients before and after the use of metronidazole and PHMB in MW. This is a randomized, double -blind study with patients diagnosed with cancer and patients with MW with odor clinical trial . The sample consisted of 24 subjects divided into 2 groups (control - metronidazole group and experimental group - PHMB ) , recruited in one cancer hospital in the city of São Paulo (AC Camargo Cancer Center), which has as protocol description in odor control MW metronidazole . After acceptance by the subject and return the Statement of Informed Consent signed , randomization will be done .

For blinding , 0.8 % metronidazole solution will be provided by a compounding pharmacy (after stability testing of tablet diluted - and then stipulated expiration date) , and PHMB be bought from the supplier , delivered to the same compounding pharmacy which stores the PHMB in identical bottles to metronidazole ( only the responsible researcher will know to which group the subject was randomized ) .

The evaluation of the odor will be taken by 3 " employees " and the patient through 3 scales at zero , four, eight and twelve days ( or earlier if classified as " odorless " by 3 reviewers and the patient ) . Two scales about painful sensations in exchange for healing , one on quality of life will be applied to the patient and a specifically on the impact of odor on the subject's life.

To meet the proposed objectives, the data will be analyzed by: Friedman test to assess the odor reduction with respect to time; Mann-Whitney (or t test) for comparison of groups and the Fisher exact test to compare proportions. Data will be presented in the form of frequency tables for categorical variables and means, standard deviations and position measurements for quantitative variables. Will also be performed non-parametric analysis of ordinal data, or parametric analysis with Generalized Estimation Equation for binomial variables, depending on the data distribution and the sample size.

Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide

Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide: Randomized Clinical Trial

Fundação de Amparo à Pesquisa do Estado de São Paulo

University of Sao Paulo

ODOR MANAGEMENT IN FUNGATING WOUDS WITH METRONIDAZOLE versus PHMB: DOUBLE-BLINDED, RANDOMIZED, CLINICAL TRIAL

Radiation Injuries

Radiodermatitis

Dermatitis

Acute Graft Versus Host Disease

Receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Receives PBMT (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

PBMT sessions will be planned 2x/week after RT.

Photobiomodulation therapy (PBMT)

Sham laser sessions will be applied 2x/week after RT.

Sham laser

Jolien Robijns, PhD

Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.

Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.

Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.

The results of this project will support the implementation of PBMT into the standard RD skincare program.

Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy

The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial

Objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC) objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)

Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.

The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds	NCT05800834	Wounds and Inju... Cancer Pain Cancer, Breast Cancer Head Nec...	Morphine Sulfat... Lidocaine Hcl 2...	18 Years -	Instituto Nacional de Cancer, Brazil
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
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide	NCT02394821	Neoplasm Wounds and Inju...	Polihexanide 2% Metronidazole 0...	18 Years -	University of Sao Paulo
Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy	NCT03924011	Radiodermatitis Breast Cancer	Photobiomodulat... Sham laser	18 Years -	Hasselt University

Spots Global Cancer Trial Database for wounds and injuries