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Covid-19
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Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3Mâ„¢ Cavilonâ„¢ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3Mâ„¢ Cavilonâ„¢ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cavilon Advanced Skin Protectant | Experimental | Cavilon Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin. The skin barrier protectant will be applied on the irradiated skin from the third week of radiotherapy until 1 week after the final radiotherapy session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cavilon Advanced Skin Protectant | Device | 3Mâ„¢ Cavilonâ„¢ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 1 |
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 14 |
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 20 |
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 35 |
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 38 |
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 47 |
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 1 |
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 1 |
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical photograph | A clinical photograph of the treatment area will be taken | day 1 |
| Clinical photograph | A clinical photograph of the treatment area will be taken |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annelies Maes, MD | Limburgs Oncologisch Centrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium | ||
| Jessa Ziekenhuis |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D011832 | Radiation Injuries |
| D012871 | Skin Diseases |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
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| Day 14 |
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 20 |
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 35 |
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 38 |
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 47 |
| day 14 |
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 20 |
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 35 |
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 38 |
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 47 |
| General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | Day 35 |
| General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | day 38 |
| General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | day 47 |
| day 14 |
| Clinical photograph | A clinical photograph of the treatment area will be taken | day 20 |
| Clinical photograph | A clinical photograph of the treatment area will be taken | day 35 |
| Clinical photograph | A clinical photograph of the treatment area will be taken | day 38 |
| Clinical photograph | A clinical photograph of the treatment area will be taken | day 47 |
| Personal and medical information | Patient's personal and medical information will be gathered via a patient questionnaire and the patient's medical file | day 1 |
| Hasselt |
| Limburg |
| 3500 |
| Belgium |
| D009369 |
| Neoplasms |