Mepilex Lite dressings to treat acute radiation dermatitis of the anal canal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with histologically confirmed rectal cancer who develop grade 2 or higher acute radiation dermatitis of the anal canal after radiotherapy. Eligible participants will receive either Mepilex Lite dressings applied to the affected anal canal area or the control approach (standard local care), with pain, skin healing, and ability to complete radiotherapy tracked over the treatment period. Mepilex Lite is a foam dressing designed to absorb exudate, keep the wound moist, and reduce pain. Safety, symptom scores, and wound healing endpoints will be recorded at planned follow-up visits at the hospital site.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Confirmed rectal cancer by histopathological diagnosis;
2. Individuals with clear indications for radiotherapy;
3. Individuals who receive radiation therapy for the first time and develop grade 2 or higher acute radiation dermatitis after receiving radiation therapy;
4. Age ≥ 18 years old;
5. Those who voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

1. Individuals with allergic constitution and allergies to the drugs and materials used in this study;
2. Those who withdraw or interrupt radiotherapy midway;
3. Individuals with mental illness, emotional instability, or inability to express their own feelings;
4. Individuals with various comorbidities such as serious cardiovascular and cerebrovascular diseases, digestive system diseases, hematological diseases, and infectious diseases;
5. Physical condition score (Eastern Cooperative Oncology Group, ECOG) \>3 points;
6. Individuals suffering from anal fissures and other diseases that cause skin damage to the anal canal;
7. Individuals with an artificial anus.

Where it's running

• The First Affiliated Hospital of Shandong First Medical University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Heli Shang, undergraduate
• Email: 1197@sdhospital.com.cn
• Phone: +8613789820123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.