Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Chung Shan Medical University

Status and phase: Completed; Phase 1

Conditions: Radiation Dermatitis

Treatments: Drug: CSMed Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06001463

CS1 20015

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

reduce the severity, and enhance healing of radiation dermatitis

Experimental group

Description:

The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.

Treatment:

Drug: CSMed Dressing