NCT06001463

Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Radiation Dermatitis

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2023-08-21
• Last updated: 2023-08-25

Locations

1 site across 1 country: Taiwan