Vavassis, P., Gelinas, M., Chabot Tr, J., & Nguyen-Tân, P. F. (2008). Phase 2 study of silver leaf dressing for treatment of radiation-induced dermatitis in patients receiving radiotherapy to the head and neck. Journal of Otolaryngology-Head and Neck Surgery, 37, 124–129.

To investigate the effectiveness of silver leaf dressings in treating radiation-induced dermatitis compared with the current standard of care (silver sulfadiazine).

Patients presenting with grade 2 or greater skin toxicity within radiation portals were offered the topical treatment of silver sulfadiazine (application three times daily and removed prior to daily radiation) and silver leaf dressing worn constantly (removed only for radiation treatments).

Each patient applied silver leaf dressing on one side of the neck and silver sulfadiazine on the other.

Silver leaf dressing and silver sulfadiazine were each assigned randomly to each side of the patient’s neck.

• Twelve patients were entered, and five completed the study.
• Age and gender were not reported.
• Patients had squamous cell carcinoma of the base of the tongue, tonsillar fossa, oropharynx, hypopharynx, or larynx.
• Radiation doses varied from 60 Gy in 30 fractions to 72 Gy in 42 fractions.
• The majority of patients received 70 Gy in 35 fractions.
• Five of the 12 patients received concurrent platinum-based chemotherapy.

The study used a quasiexperimental design; patients were used as their own controls.

• Patients were evaluated weekly (or more) by a treating physician. At evaluations, patients were questioned regarding quality of pain control by the treating physician and an independent research coordinator.
• Radiation Therapy Oncology Group (RTOG) acute skin toxicity scoring system was used to grade dermatitis.
• Digital photographs were taken to establish baseline skin status, as well as for follow-up during and after.
• Three physicians were presented with digital photographs and were asked to evaluate and grade skin toxicity, as well as compare both sides of the head and neck of patients.

• No difference in improvement was reported between the control and test sides in any patient with regard to RTOG grade throughout the duration of application of both modalities. However, within the same grade, two of three observers agreed on some degree of improvement in dermatitis with silver leaf dressing compared with silver sulfadiazine.
• Eight of the 12 patients (67%) subjectively reported improved pain control on the side treated with silver leaf dressing.
• Seven of the 12 patients (58%) on the silver leaf dressing treatment side presented with smaller regions of same-grade dermatitis with a tendency toward faster healing.
• Four of the 12 patients (33%) had equivalent results with both treatment modalities.
• Duration of healing varied between 7 and 28 days.
• Within the same RTOG grade, sliver leaf dressing appeared to provide greater relief of pain and greater skin condition.

Silver leaf dressing does not appear to be superior to standard treatment for radiation-induced dermatitis when the RTOG grading system is used.

• The study had a very small sample, and less than one-half of patients completed the study.
• No formal pain assessment scale was consistently used during pain assessment.
• The potential impact of concurrent chemotherapy on healing could not be evaluated or discussed.
• Because of the subjective nature of evaluation of dermatitis within RTOG grade, the opinion of the majority of observers served to classify response of dermatitis. It would be more reliable to have averaging of observations.
• The study lacked strict guidelines to ensure conformity to treatment.