Objective: This study evaluated the effectiveness of a medical topical treatment device named Silver Cap(®) (Depofarma S.P.A., Mogliano Veneto, Treviso, Italy) for the treatment of nipple fissure in lactating women and its local tolerability, compared with the standard of care for nipple fissure treatment during breastfeeding.
Subjects and methods: From December 2013 to September 2014, we recruited 40 women for symptomatic nipple fissures during lactation. Participants were randomized into two groups: the Silver Cap group (20 women; group A) or the control group (20 women; Group B, standard of breastfeeding care). All participants received breastfeeding education provided by a board-certified lactation consultant. Group A was instructed to use the Silver Cap. Group B had a handbook with the standard of care for nipple treatment after each breastfeeding. Both groups received a questionnaire for a daily assessment. The duration of both treatments was 15 days. We performed a clinical evaluation on Days 0 and 2 and a follow-up by telephone on Day 7, and all participants underwent final evaluation face to face on Day 15. We performed photographic recording of the nipple on Day 0 and Day 15.
Results: There were no statistical differences in follow-up between the two treatments at Day 2. There was a significant and a more rapid resolution of painful symptoms in the Silver Cap group compared with the control group (p<0.05) at Days 7 and 15. Treatment with Silver Cap was more appreciated by the participants than standard care (p<0.05). Four participants in the Silver Cap group and six in the control group dropped out of the study. No local or systemic reactions were reported following Silver Cap application.
Conclusions: Results of treatment with Silver Cap were more effective than standard care of nipple fissure treatment in term of resolution of painful symptoms. It promoted the healing process of lesions, and it was well tolerated and accepted by participants.