Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiation Dermatitis Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chung Shan Medical University

Taichung, 408025, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSMed Dressing

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.

Primary outcomes

Severity of acute radiation dermatitis

Time frame: 4 weeks

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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Aug 21, 2023
Registry last updated: Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed