Diggelmann, K.V., Zytkovicz, A.E., Tuaine, J.M., Bennett, N.C., Kelly, L.E., & Herst, P.M. (2010). Mepilex Lite dressings for the management of radiation-induced erythema: A systematic inpatient controlled clinical trial. The British Journal of Radiology, 83(995), 971–978.

• To determine the clinical efficacy of Mepilex Lite dressings in reducing radiation-induced erythema in women with breast cancer receiving radiation therapy treatments 
• To determine the effect of Mepilex Lite dressings on dose build-up and on surface skin temperature
• To determine the dose distribution over the breast
   

When erythema was visible (generally 10–14 days after first fraction), each affected skin area was randomly divided into two similar halves: one was treated using Mepilex Lite dressings, the other with standard aqueous cream. Mepilex Lite dressings are absorbent, self-adhering dressings consisting of a thin flexible sheet of absorbent hydrophilic polyurethane foam bonded to a water vapour-permeable polyurethane film backing layer. The contact surface of the dressing is coated with a soft silicone adhesive layer without any added chemicals, providing a moist wound-healing environment. Dressings were positioned by a research radiation therapist on half of the area where erythema was present, with the location marked by semi-permanent marker so patients could accurately reposition dressings after showering. The other half continued to be treated with aqueous cream. Allocation of dressings and controls was random based on order of entry into the trial. Skin areas were designated as superior/medial or inferior/lateral. Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scores were determined three times a week (Monday, Wednesday, and Friday) from the moment erythema was visible until completion of radiation treatment. Two more assessments were completed one week after completion of treatment and at the final check-up (usually four weeks after completion of treatment). Because anecdotal evidence suggested the dressings may have a cooling effect, skin temperature of the 10 patients was measured three times a week during every skin assessment. The study endpoint was development of dry desquamation as departmental protocol is to cover any area of dry desquamation with Mepilex Lite dressings, thus removing control side of clinical trial.
 

• The study sample (N = 24) was comprised of female patients receiving radiation therapy treatment for breast cancer.
• Mean age was 58 years, with a range of 43–79 years.
• A total of 34 areas of erythema were treated (eight women had two separate areas for analysis and one woman had three separate areas for analysis).
• Patients were excluded from the study if they had radical mastectomy, fractionation regimes other than 50 Gy per 25 fractions, prone treatment position, impaired mobility, or fungating tumor.
• One woman was Maori/Lebanese and all others were Caucasian.
• Surface areas analyzed ranged from 50–150 cm².
• Chemotherapy was given prior to radiation treatment for six women (5- ACT, 1- FEC). 
• Five women smoked at time of study and seven women had previously smoked. 
• All trial participants received 50/25 fractions; in addition, four women received boosts to their axilla and upper-outer breast quadrant and one woman received a boost to the superior anterior breast and upper-inner breast quadrant.

The study took place at a single site in New Zealand.

Patients were undergoing the active treatment and transition phase. The study has clinical applicability to late effects and survivorship care.
 

The study used a quasi-experimental, unblinded design. The study was labeled by investigators as a systematic inpatient randomized controlled clinical trial.

• Extent of erythema was measured using a modified RISRAS scale. The scale consists of a research component (visible extent of skin reaction) and a patient component (level of pain, itchiness, burning and effect on day-to-day life). Because the trial end point was dry desquamation, only extent of erythema (0–4) was included in the research component.
• Tissue maximum ratio measurements were taken at various depths when a Mepilex Lite dressing was applied to the surface to calculate its bolus effect. Measurements were taken with a white water phantom chamber in combination with PTW Unidos E electrometer.  Readings were made with and without the Mepilex Lite dressing on the surface of the phantom over the chamber.  The maximum value was determined for each energy level.
• Surface skin temperature was measured using an infrared thermographic scanner to detect subtle skin temperature variations scores across the control and Mepilex areas. Skin temperature was measured for the first 10 patients three times a week during every skin assessment.
• Thermoluminescent dosimeters (TLDs) were used to calculate the actual dose received by the skin in different areas of the breast, comparing dose that had been received with the dose that the planning system intended giving. They were also used as a reference point for the level of skin reaction experienced by the patient. TLDs were placed in seven areas on the breast as outlined per protocol.

• Mepilex Lite dressings had a very small bolus effect. The difference in dose between Mepilex and control under two different beams was shown to decrease with depth, demonstrating a 0.5 mm difference in dose build-up.
• Mepilex Lite dressings decreased the extent of radiation-induced erythema. The average increase in combined, researcher and patient RISRAS scores for the 34 areas of skin analyzed showed the dressings significantly decreased the extent of the radiation-induced erythema (p < 0.001). Most of the patients (71%) preferred the dressings over the cream and commented that the dressings were soothing, providing pain relief and relief from friction.
• Mepilex Lite dressings did not affect surface skin temperature. The average difference between the surface skin temperature of the dressed and undressed areas was statistically insignificant in the first 10 patients (p = 0.77). Temperature measurements were not completed in the remainder of patients.
• Breast regions at risk from radiation-induced side effects were measured by TLDs. The inframammary fold received the highest dose regardless of breast size, which was highly statistically significant (p < 0.00001). Most patients (67%) developed moist desquamation in their inframmary fold. 
• Twenty-four percent of skin areas treated with aqueous cream broke down to reach dry desquamation. These patients were stopped from further participation in the trial as departmental protocol was to apply Mepilex Lite dressings to dry desquamation. Fifteen percent of skin areas dressed with Mepilex Lite developed dry desquamation. Dry desquamation led to moist desquamation in all instances, suggesting that the dressings may decrease the number of skin areas reaching moist desquamation. Moist desquamation was not part of the trial outcomes.
   

Mepilex Lite dressings decreased the severity of radiation-induced erythema in patients with breast cancer treated with radiation therapy. The majority of patients preferred the dressings over the cream and thought they increased comfort levels, decreased the amount of pain experienced, and allowed patients to wear normal clothing. Mepilex Lite dressings did not affect surface skin temperature and did not cause a significant dose build-up.  
 

• The study had a small sample size, with less than 30 patients.
• The study took place at a single site.
• The study had a potential risk for bias because of randomization of skin areas based on date of entry to the trial (computer-generated randomization numbers should be considered in future trials) and lack of blinding.
• Most insurances do not cover dressings for non-draining skin issues. The expense of application of Mepilex Lite dressings at the time of erythema would be cost prohibitive to many patients undergoing radiation treatment.
• The end point of this trial was dry desquamation. RISRAS measurements were stopped when the end point was reached, possibly obscuring the effects of Mepilex Lite dressings as skin toxicity progresses to moist desquamation.
   

What are insurance implications for patients who would potentially benefit from Mepilex Lite? Further studies with larger sample sizes, multiple centers, and other treatment areas known to demonstrate increased skin toxicity are needed.