Appendix 9: Evidence relating to the use of dressings in the management of radiotherapy induced skin reactions ++= high quality study += acceptable quality 0= rejected, unacceptable quality not able to score= study had no control/comparison group or a case series Dressing Type Product Design of Study (including method, sample and main outcomes) Reference Main Findings and Limitations Quality Assessment Silicone-based foam Low adhesion Mepilex®Lite Systematic controlled clinical trial (patients as own control) comparing Mepilex®Lite and Aqueous cream BP in women treated with radical RT to breast N=24 evaluable Outcomes: Skin Reaction Assessment Scale (RISRAS), dose build-up, skin temperature Diggelmann, K., Zytkovicz, A., Tuaine ,J. et al. 2010. Mepilex ®Lite dressings for the management of radiation-induced erythema: a systematic inpatient controlled clinical trial. Brit J Radiol 83: (995), 971–8. Mepilex®Lite dressings statistically significantly decreased the extent of radiation-induced erythema (p<0.001) although the average increase in erythema score for Mepilex® Lite was 1.65 and the average increase in erythema score for Aqueous cream BP was 2.41 (average difference =0.76) giving an average difference less than one category point on the scale so may not be clinically significant. The majority of women preferred them. Bolus 0
effect was very small (0.5mm) and no difference in skin temperature was found. Limitations: small trial, RISRAS measurements stopped when dry desquamation occurred, so effect on more severe skin reactions not assessed. No blinding of assessors and no allocation concealment. Silicone- foam Low adhesion Mepilex®Lite Randomised controlled trial (patients as own control) comparing Mepilex®Lite and Aqueous cream BP on first area of erythema to appear during radical RT to breast post mastectomy. N=74 evaluable patients. Outcomes: RISRAS, time to moist desquamation, time to healing Paterson, D., Poonam, P., Bennett, N., et al. 2012) Randomized controlled trial of Mepilex ®Lite dressings versus Aqueous cream BP in managing skin reactions postmastectomy. JCancer Sci Ther 04:347-56. NB preliminary results also reported in Bennett N et al. 2013. Proceedings from RTi3 2013: Inquire, Inspire, Mepilex®Lite dressings did not significantly reduce the incidence of moist desquamation, but reduced the overall severity of skin reactions by 41% (p < 0.001) and the average moist desquamation score by 49% (p = 0.043). 80% of participants said they preferred the dressings over the cream and RISRAS scores for pain/discomfort, itchiness, burning and effect on day to day life were significantly better in the Mepilex®Lite area. Limitations: study only compared dressings applied + patient
Outcomes: pain and sleep diary, healing Supplement), 23(10), S24, 26-31 in another 7 patients. Patients and carers were able to change the dressings themselves. Limitations: small, uncontrolled study Silicone-based transparent film Mepitel® film Randomised controlled trial comparing prophylactic Mepitel® film with Aqueous cream BP (patients as own control) during RT for breast cancer N = 80 Outcomes: skin reaction severity, incidence of moist desquamation Hers, P., Bennett, N., Sutherland, A., Peszynski, R., Paterson, D., Jasperse, M. 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 110:1, The study reported 0% moist desquamation rates for the Mepitel® covered areas and 26% for the control areas (p<0.0001). Mepitel® film significantly decreased the combined, researcher and patients RISRAS scores (p < 0.0001) by 92% (compared with the Aqueous cream BP areas). The majority of patients (n=55) preferred Mepitel® film to cream because it felt comfortable and protective. Limitations: as with other ‘within patient’ trials, it was impossible to blind the trial. 0 Non adhesive Silver clear nylon dressing (SCND) Randomised controlled trial – Phase III study comparing silver clear nylon dressing with sulfadiazine cream in Niazi, T., Vuong, T., Azoulay, L., Marijnen, C., Bujko, K., Nasr, E. et al. 2012. Silver clear Mean dermatitis score on the last day of RT (assumed to be the point at which skin reactions were at their worst) was 2.53 (standard deviation [SD], 1.17) ++
patients with rectal or anal cancer receiving external beam RT at the point grade 1dermatitis became present. N = 40 Outcome: skin toxicity on final day of treatment nylon dressing is effective in preventing radiation-induced dermatitis in patients with lower gastrointestinal cancer: results from a phase III study. Int J Radiat Oncol Biol Phys 1: 84:e305–e310. in the standard arm and 1.67 (SD, 1.2; P=.01) in the SCND arm. 2 weeks after RT, the difference was 0.39 points in favour of SCND Limitations: This was a small single blind study. There were differences between the histological diagnosis of the patients and the concurrent chemo/ radiotherapy regimes. No patient reported outcomes were used.