Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Study Overview
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Brief Summary
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Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).

Detailed Description
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A prospective study was conducted at the University Hospital Medical Center. The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record the difference between the part of the skin with dressing and undressed skin for each patient. The severity of acute radiation dermatitis was graded using the RTOG clinical scoring standard. From the beginning of the treatment to 4 weeks after the end of the treatment, skin pain, itching, local fever and tightness, as well as skin healing time were collected every week.

Official Title
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CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: CSMed Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving radiation therapy (including undamaged skin and RTOG grade 1 dermatitis). Patients who voluntarily agree to participate in the trial and sign the subject's consent form. Exclusion Criteria: Patients with dermatitis and burns not caused by radiation therapy. Involuntary patients without signed consent. Those who are allergic to the ingredients in this product.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reduce the severity, and enhance healing of radiation dermatitis<br>The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. | Drug: CSMed Dressing<br>* Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. An irradiated area of 11cm*14cm with best fit or easy accessibility was chosen for CSMed® dressing application. The area without dressing was treated with routine skin care in each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of acute radiation dermatitis | The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5. NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases. NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds. NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis. NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event. Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record. | 4 weeks |