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Mepilex Lite dressings combined with indomethacin suppositories may improve treatment efficiency of acute radiation dermatitis of the anal canal skin in rectal cancer patients undergoing radiotherapy.

This protocol describes an assessor-blinded RCT to evaluate the efficacy and safety of adding Mepilex Lite dressings to indomethacin suppositories for acute radiation dermatitis of the anal canal skin. The primary outcome is treatment efficiency at day 14 post-intervention, with secondary outcomes at days 7 and 21, plus pain, anxiety/depression, sleep quality, and quality of life. The study plans to enroll 274 patients, but results are not yet reported.

Last updated: Aug 3, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Clinical efficacy of Mepilex Lite dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis caused by rectal cancer radiotherapy: a study protocol for a randomised controlled trial.

observational

Shang H, Yang Y, Cao H, Wu Y, Ji H · BMJ open (2026)

Participants: N/A
Duration: 21 days post-intervention
Intervention: Mepilex Lite dressing (5 cm x 5 cm, inserted 3 cm into anal canal, exposed 2 cm) plus indomethacin suppositories (30 mg rectal) vs indomethacin suppositories alone
Outcome: Treatment efficiency of acute radiation dermatitis of anal canal skin at day 14 (primary), also at days 7 and 21; pain (Numeric Rating Scale), anxiety/depression (Hospital Anxiety and Depression Scale), sleep quality (Pittsburgh Sleep Quality Index), quality of life (Skin Disease Patient Quality of Life Scale-16)
Effect Size: N/A (protocol, no results)
Population: Rectal cancer patients undergoing radiotherapy with acute radiation dermatitis of the anal canal skin (n=274 planned)

Result:

PubMed: 42532557DOI: 10.1136/bmjopen-2026-122248

Mechanism Graph

Radiotherapy induces acute radiation dermatitis of anal canal skin, causing pain and inflammation
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Indomethacin suppository reduces inflammation and pain via prostaglandin inhibition
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Mepilex Lite dressing provides a moist wound healing environment and protects the skin from friction
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Combined intervention may improve healing and reduce symptoms, leading to higher treatment efficiency

Limitations

  • ⚠Results not yet available; efficacy and safety remain unverified
  • ⚠Single-center study may limit generalizability
  • ⚠Assessor-blinded but not double-blinded, potential performance bias
  • ⚠No long-term follow-up beyond 21 days

Frequently Asked Questions

What is the primary outcome of this trial?▼

The primary outcome is the treatment efficiency of acute radiation dermatitis of the anal canal skin on the 14th day after intervention.

How is the Mepilex Lite dressing applied?▼

A 5 cm x 5 cm dressing is inserted into the anal canal for 3 cm through the anus, with 2 cm exposed.

What is the sample size and design?▼

The trial plans to enroll 274 eligible patients, randomized 1:1 to intervention (Mepilex Lite plus indomethacin) or control (indomethacin alone). It is an assessor-blinded RCT.

Has the study been approved and registered?▼

Yes, ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (approval number: YXLL-KY-2024 (162)), and the trial is registered as NCT06837831.

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References

  1. 1.Shang H, Yang Y, Cao H, Wu Y, Ji H. "Clinical efficacy of Mepilex Lite dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis caused by rectal cancer radiotherapy: a study protocol for a randomised controlled trial.." BMJ open, 2026. PMID: 42532557 DOI: 10.1136/bmjopen-2026-122248
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.