Mepilex Lite dressings to treat acute radiation dermatitis of the anal canal
Clinical Efficacy of Mepilex Lite Dressings Combined With Indomethacin Suppositories in the Treatment of Acute Radiation Dermatitis Caused by Rectal Cancer Radiotherapy: a Randomized Controlled Trial
This trial will try Mepilex Lite dressings to reduce pain and help heal acute radiation skin damage inside the anal canal for adults receiving radiotherapy for rectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06837831 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with confirmed rectal cancer who are undergoing radiotherapy for the first time and develop grade 2 or higher acute radiation dermatitis of the anal canal and can give informed consent.
Not a fit: Patients with known allergies to dressing materials, serious comorbidities, ECOG performance status >3, those who withdraw or interrupt radiotherapy, or with uncontrolled anal fissures may not receive benefit from the dressing intervention.
Why it matters
Potential benefit: If successful, patients could have less anal pain, faster healing of radiation-induced skin injury, and a better chance of completing their planned radiotherapy.
How similar studies have performed: Foam dressings such as Mepilex have shown benefit for radiation dermatitis at other body sites in prior work, but their application inside the anal canal is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.