Niazi, T. M., Vuong, T., Azoulay, L., Marijnen, C., Bujko, K., Nasr, E., . . . Cummings, B. (2012). Silver clear nylon dressing is effective in preventing radiation-induced dermatitis in patients with lower gastrointestinal cancer: results from a phase III study. International Journal of Radiation Oncology, Biology, Physics, 84, e305-e310.

To compare the efficacy of silver clear nylon dressing to standard skin care for the prevention and treatment of radiodermatitis in patients with anal canal and rectal cancer receiving chemoradiation therapy (XRT).

Patients were randomized to receive the silver dressing beginning on day 1 of radiation treatment or standard of care if radiation-induced dermatitis developed. Standard care involved using sulfadiazine cream at the time of development of grade 1 dermatitis. Patients wore the dressing 24 hours/day, seven days/week, except during XRT delivery. This was continued until two weeks after completion of XRT. The primary study outcome was skin toxicity at the last day of XRT. Skin toxicity was rated by multiple observers from digital photographs of the perineal skin area.

• The sample was comprised of 38 patients (50% male, 50% female).    
• Mean age was 63.8 years.
• Of the patients, 70% had disease of the anal canal and the rest had rectal cancer.
• Of the patients, 75% had 54 Gy or more of XRT. All received concurrent chemotherapy with 5 FU. Those with anal canal disease also received mitomycin C.

• Single site 
• Outpatient 
• Canada

Patients were undergoing the active antitumor treatment phase of care.

Skin scoring system grade 0–4:  grading by all 10 observers was calculated as the average score x10.

All patients completed XRT without major toxicity. There were four treatment breaks in the standard care arm and three in the silver dressing arm. On the last day of treatment, the mean dermatitis score was 2.53 for the standard arm and 1.67 for the silver dressing arm. When adjusted for age, there was no significant difference between groups in terms of severity of radiodermatitis.

There were no clear differences between study groups that indicated a substantial benefit for use of silver dressings.

• The study had a small sample size.
• The study had a risk of bias due to no blinding.
• Measurement/methods were not described.
• Measurement validity/reliability was questionable.*
• The intervention was expensive, impractical, or required training.*

*Dressings were provided free of charge; however, they are generally expensive. Measurement methods were unclear; the authors stated calculation of dermatitis severity using all 10 observer scores but then reported analysis only of average findings in each group. Findings showed no significant difference or meaningful size of effect; however, the authors concluded that the dressing was beneficial, which showed bias in the reporting.

The study did not provide strong support for the efficacy of silver nylon dressing to prevent radiation-induced dermatitis with radiation to the perineal area and skin.