Aquino-Parsons, C., Lomas, S., Smith, K., Hayes, J., Lew, S., Bates, A. T., & Macdonald, A. G. (2010). Phase III study of silver leaf nylon dressing vs standard care for reduction of inframammary moist desquamation in patients undergoing adjuvant whole breast radiation therapy. Journal of Medical Imaging and Radiation Sciences, 41, 215–221.

To evaluate the use of silver leaf nylon dressings as a prophylactic measure to reduce inframammary fold radiation therapy (RT)–induced dermatitis in women receiving adjuvant whole-breast RT compared with standard skin care. The secondary objective was to evaluate if the dressing influenced breast skin–related pain, itching, and burning resulting from whole-breast RT.

Patients were randomized during their first week of RT using a random numbers table after stratification for prior anthracycline-based chemotherapy and duration of RT:  short course (42.5 Gy/16 fractions) or extended course (45-50 Gy/25-28 fractions).

Control Arm (n = 103):  Standard skin care recommendations included avoiding skin irritants, promoting clean skin using nonalkaline, unscented soap and water and patting skin dry, and maintaining skin hydration with twice daily (BID) application of moisturizing cream (patients chose which brand of cream they used). Pruritis or brisk erythema was managed with topical steroids. Moist desquamation was treated with BID saline compresses and hydrogel or silvadene cream.

Experimental Arm (n = 93):  Patients were supplied with dressings, sterile water, a cotton bra in the correct size, gauze, hypoallergenic tape, printed instructions, and teaching performed by RT therapists to show patients how to wear the dressing before day six of RT. Sterile water was used to moisten the dressing before applying it to the inframammary fold with gauze to cover it. This was held in place with the cotton bra and was to be worn 24 hours per day but removed for RT and bathing. The dressing was worn from day 6 of RT until 14 days after completion of whole-breast RT. Women in this arm also received standard skin care instruction. Patients were assessed one week before the last treatment, on the final day of treatment, and one week posttreatment (the time period when RT-induced dermatitis was likely to have appeared in the inframammary fold). Subjective and objective assessments of radiodermatitis in the inframammary fold were performed at these time points.

• The sample was comprised of 196 patients (100% female) with breast cancer.
• Mean age was 56 years in the control group and 58 years for silver leaf dressing group.
• Patients were undergoing whole-breast RT for in-situ or invasive breast cancer after breast-conserving surgery.
• Patients were excluded if they had an allergy to silver, significant connective tissue disease, known RT hypersensitivity syndrome, or significant wound complication (infection or dehiscence).

Canada:  The British Columbia Cancer Agency

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

• Digital photographs    
• Radiation Therapy Oncology Group (RTOG) visual score to grade acute toxicity of RT-induced skin erythema
• Breast questionnaires specifically developed for the study

• Objective data assessment:  RTOG scores showed no significant difference in the presence of or maximum area of moist desquamation, erythema, or RTOG skin toxicity between study arms.
• Subjective data assessment:  Symptoms of pain, burning, and itching increased during RT. Two weeks after completion of whole-breast RT, these symptoms had not returned to baseline. There was no difference between the study arms in patients reporting symptoms of pain or burning. In the last week of RT and one week post completion of RT, patient reports of itching decreased in the experimental arm (p = 0.013 and .019, respectively). Patients using Glaxal Base cream reported worse burning one week before RT finished (p = 0.02), and those who used aloe vera reported worse pain and burning (p = 0.006 and p = 0.003, respectively). Patients who had not used moisturizing cream reported less pain (p = 0.02).

The use of silver leaf nylon dressings as a prophylactic measure did not show benefit in reducing the degree of acute inframammary fold radiodermatitis in women receiving adjuvant whole-breast RT.

• Not applicable
• The authors identified potential reasons for negative outcomes:  weakness in study design/implementation or that the silver leaf dressing had no effect in preventing inframammary radiodermatitis.  

The prophylactic use of silver leaf nylon dressings decreased the patient-reported symptom of itching on the last day of RT and one week after completion of whole-breast RT. Dressings can provide patient comfort, and the use of dressings is supported perhaps on a more individual per-case basis; however, the results did not demonstrate a significant benefit for prophylactic silver leaf dressing use.