Mepilex Lite Dressings for the Treatment of Acute Radiation Dermatitis of Anal Canal Skin

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

Background: According to GLOBOCAN 2022 statistics, colorectal cancer has become the third most common cancer disease worldwide, and also the second leading cause of death. The incidence rate of rectal cancer is particularly prominent. Radiotherapy is one of the important methods for comprehensive treatment of rectal cancer, but the radiation damage caused by radiotherapy cannot be ignored. During radiotherapy for rectal cancer, the skin of the anal canal will be damaged by radiation, resulting in acute radiation dermatitis, which is characterized by redness, pain, and ulcers. The main symptom of patients is anal pain. As the radiation dose accumulates, the skin damage to the anal canal becomes increasingly severe, and the patient's anal pain becomes more severe, which seriously affects the patient's quality of life. Mepilex Lite Dressings can absorb the exudate, keep it moist, promote the healing of radioactive dermatitis, and relieve pain. However, when inserting into the anal canal, the patient reported significant pain that was difficult to tolerate. Therefore, indomethacin suppositories were administered rectally before inserting the dressing, which has been proven to have a reliable analgesic effect by research. In summary, the main objective of this study is to determine the effectiveness of Mepilex Lite Dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis of anal canal skin in patients with rectal cancer undergoing radiotherapy.

Method: The research plan will be a prospective randomized controlled trial. Participants were randomly divided into an experimental group (n=137) and a control group (n=137) using a simple randomization method. The control group received indomethacin suppositories and routine nursing measures, while the experimental group received the same treatment as the control group and received insertion of Meipile Lite Dressing into the anal canal. The primary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 14th day after intervention, and the secondary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 7th and 21st days after intervention. At the same time, a questionnaire survey was conducted using the Digital Pain Assessment Scale, Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and Skin Disease Patient Quality of Life Scale at baseline and on the 7th, 14th, and 21st days after intervention.

Study Overview

• Status: Recruiting
• Conditions: Acute Radiation Dermatitis; Rectal Cancer, Radiotherapy; Anal Pain; Anal Canal
• Intervention / Treatment: Other: Control group; Combination product: Experimental group

Detailed Description

Rectal cancer is a common type of cancer, and radiotherapy is an important treatment method, which is of great significance for the treatment of rectal cancer. But the adverse reactions of radiotherapy also make patients feel extremely painful. The common adverse reactions of radiotherapy for rectal cancer mainly include radiation enteritis, clinically manifested as diarrhea, abdominal pain, urgency, anal pain, etc. Among them, anal pain is very painful for patients. In clinical practice, anal pain is usually considered a normal adverse reaction of radiotherapy, and is only treated with medication to alleviate pain. After the efficacy of the medication, patients may experience pain again, especially during defecation, which seriously affects their quality of life.

Through physical examination, it was found that the tissues inside the patient's anus had been damaged or even ulcerated. This area is the anatomical anal canal, from the dentate line to the anal margin. This area is covered with non-keratinized stratified squamous epithelium and is an unnatulated skin that is extremely sensitive to pain and other conditions. As the radiation dose accumulates, the anal canal skin is continuously irradiated and damaged, resulting in acute radiation dermatitis of the anal canal skin. Therefore, the patient complains of significant pain.

In order to alleviate patients' anal pain and ensure the successful completion of radiotherapy, it was found that the mepilex lite dressings was effective in the treatment of radiation dermatitis after consulting the literature, but as far as we know, it has not been applied to the treatment of anal canal skin radiation dermatitis. Therefore, this study is a bold attempt to insert mepilex lite dressings into the anal canal to verify its effectiveness in treating anal canal skin radiation dermatitis, and whether it can reduce pain and improve the quality of life of patients.

• Study Type: Interventional
• Enrollment (Estimated): 274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heli Shang, undergraduate; Phone Number: +8613789820123; Email: 1197@sdhospital.com.cn
• Study Contact Backup: Name: Yanwei Yang, postgraduate; Phone Number: +8615863788372; Email: 15863788372@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University
      • Contact: Yanwei Yang, postgraduate; Phone Number: +8615863788372; Email: 15863788372@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; On the basis of routine care, patients will be given 30 mg of indomethacin suppositories for rectal administration after emptying their stool and urine before bedtime (21:00).	Other: Control group; Control group: All patients will receive routine care, including informing them to gently clean the perianal skin with warm water after each bowel movement, and gently wiping it with a cotton cloth. They will also wear loose cotton underwear to keep the perianal skin clean and dry. We will guide patients to consume high protein, high vitamin, and low fiber foods, and avoid spicy and stimulating foods,et al.On the basis of routine care, patients will be given 30 mg of indomethacin suppositories for rectal administration after emptying their stool and urine before bedtime (21:00).
Experimental: Experimental group; In addition to the measures applied to the control group, patients in the experiment group will be given Mepilex Lite Dressings combined with Indomethacin Suppositories.	Combination product: Experimental group; Experiment group: In addition to the control group interventions, patients received Mepilex Lite dressings inserted into the anal canal. A 30 mg indomethacin suppository was administered rectally 30 minutes before dressing placement. Patients were placed in the left lateral position with knees flexed. The anal canal was cleaned with cotton swabs moistened with 0.9% sodium chloride solution and air-dried. The anus and injured anal canal skin were exposed, and a 5 cm × 5 cm dressing was applied to the wound with the adhesive side facing the lesion. During exhalation, the dressing was gently inserted 3 cm into the anal canal with 2 cm remaining externally, ensuring full adherence to the damaged tissue. Patients were advised to rest in bed and avoid defecation. Dressings were removed the next morning and replace if dislodged prematurely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effective rate of anal canal skin radiation dermatitis	On the 14th day after intervention, the evaluation of the effectiveness of treatment for anal canal skin radiation dermatitis will be conducted using the RTOG acute radiation dermatitis grading standard.	From enrollment to day 14 after intervention treatment

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Study Director: Heli Shang, undergraduate, Shandong First medical university

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rectal cancer; Anal Canal; mepilex lite dressings; indomethacin suppository; anal pain; Acute radiation dermatitis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: Zlflk2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, data generated in later studies will be published in the form of a paper
• IPD Sharing Time Frame: The study protocol and informed consent were published at the time of clinical trial approval.; The statistical analysis plan and clinical study report will be published following publication of the paper, approximately December 1, 2027.; The above information is valid for 3 years after publication.
• IPD Sharing Access Criteria: Everyone can access it via ClinicalTrials.gov or by email directly to 15863788372@163.com.All individuals may access the study protocol, statistical analysis plan, and informed consent forms.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No