Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-05-31

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).

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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.

Conditions

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Radiation Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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reduce the severity, and enhance healing of radiation dermatitis

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

Group Type EXPERIMENTAL

CSMed Dressing

Intervention Type DRUG

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.

Interventions

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CSMed Dressing

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.

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No