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

NCT06837831 | Recruiting

• 1 other identifier: Zlflk2025
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer, Radiotherapy; Anal Pain; Acute Radiation Dermatitis; Anal Canal

Keywords

Rectal cancer; mepilex lite dressings; indomethacin suppository; anal pain; Acute radiation dermatitis; Anal Canal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

OTHER

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

Experimental group

EXPERIMENTAL

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

Interventions

Control group OTHER

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).

Control group

Experimental group COMBINATION_PRODUCT

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Heli Shang, undergraduate

  Shandong First Medical University

  STUDY DIRECTOR

Central Study Contacts

Heli Shang, undergraduate

CONTACT

+8613789820123; 1197@sdhospital.com.cn

Yanwei Yang, postgraduate

CONTACT

+8615863788372; 15863788372@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1. The study protocol and informed consent were published at the time of clinical trial approval. 2. The statistical analysis plan and clinical study report will be published following publication of the paper, approximately December 1, 2027. 3. The above information is valid for 3 years after publication.
• 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.

Locations

CN (1)