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.
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 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.
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.
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.