Herst, P.M., Bennett, N.C., Sutherland, A.E., Peszynski, R.I., Paterson, D.B., & Jasperse, M.L. (2014). Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiotherapy and Oncology, 110, 137–143. 

To evaluate the prophylactic use of a Safetac product, Mepitel Film, on moist desquamation rates

At the start of radiation treatment, the breast or chest wall was divided into medial and lateral halves, and sections were randomly assigned to treatment with either Mepitel Film or aqueous cream. Mepitel Film was applied at the start of radiation treatment by the research radiation therapist on either the entire lateral or the entire medial part of the breast or chest wall to be irradiated as randomly assigned, and aqueous cream was applied twice daily to the control area by the patients.

The date of onset and location of moist desquamation were recorded for each patient. Moist desquamation was treated according to the standard departmental protocol consisting of Mepilex Lite dressings. Mepitel Film was left on during radiation because it had been determined that the Film has a clinically insignificant bolus effect of 0.12 mm. Follow-up assessment was done up to four weeks after the completion of treatment.

• N = 78 included for analysis
• MEAN AGE = 59.9 years
• AGE RANGE = 30–94 years
• MALES: 2.56% (2 men), FEMALES: 97.44% (76 women)
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Most were of European ethnicity. Patients did not have concurrent chemotherapy. Most patients had 40–50 Gy in 15–25 fractions.

• SITE: Single center—University of Otago  
• SETTING TYPE: Clinic    
• LOCATION: New Zealand

• Phase-III, randomized trial
• Intrapatient, controlled, single-center trial

Skin reaction severity was assessed using the radiation-induced skin reaction assessment scale (RISRAS) and Radiation Therapy Oncology Group (RTOG) scales.

Overall skin reaction severity was reduced by 92% (p < 0.0001) in favor of Mepitel Film (RISRAS). All patients developed some form of reaction on cream-treated skin, which progressed to moist desquamation in 26% of patients (RTOG grades I: 28%, IIA: 46%, IIB: 18%, III: 8%). Only 44% of patients had a skin reaction under the Film, which did not progress to moist desquamation in any of the patients (RTOG grades I: 36%, IIA: 8%). No patients had moist desquamation with the Mepitel Film. No relationship existed between smoking, skin type, or other patient variables and skin toxicity results. Patients who received hypofractionation were less likely to develop moist desquamation than others (p = 0.012).

Mepilex Film was effective in preventing severe skin reactions.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• The Mepilex Film was in situ for days at a time
• Neither the research radiation therapist nor the patients were blinded to which skin area had been randomized to Mepilex Film and which to cream.

Mepital Film use may be an effective approach to prevent severe radiodermatitis in patients treated for breast cancer. Further research to confirm these findings in other patient groups is warranted.