Breastfeeding is drastically decreasing over time and nipple trauma constitutes one of the most significant reasons for its discontinuation. In this context, this study aimed at evaluating the effectiveness and tolera...Breastfeeding is drastically decreasing over time and nipple trauma constitutes one of the most significant reasons for its discontinuation. In this context, this study aimed at evaluating the effectiveness and tolerability of a topical treatment device, namely Silver Cap<sup>®</sup> (Depofarma S.P.A.), when used to prevent pain and nipple fissure formation. The medical device consists in a silver trilaminate cup to be placed on the nipple, providing physical protection and creating a moist environment. The study involved 187 women: 38 started to apply the device prior to lactation (PL group) and 149 during lactation (DL group). Aiming to collect safety and performance data, both groups were provided with questionnaires during 6 consecutive visits (120 days of follow-up). At last visit, absence of painful symptoms was reported by the 98.8% and the 100% of women in DL and PL groups, respectively. Moreover, no nipple fissures were observed and no adverse events directly correlated to use of the device were reported. According to these findings, it can be concluded that Silver Cap<sup>®</sup> is a safe and effective device for nipple pain and fissure prevention. .展开更多
文摘Breastfeeding is drastically decreasing over time and nipple trauma constitutes one of the most significant reasons for its discontinuation. In this context, this study aimed at evaluating the effectiveness and tolerability of a topical treatment device, namely Silver Cap<sup>®</sup> (Depofarma S.P.A.), when used to prevent pain and nipple fissure formation. The medical device consists in a silver trilaminate cup to be placed on the nipple, providing physical protection and creating a moist environment. The study involved 187 women: 38 started to apply the device prior to lactation (PL group) and 149 during lactation (DL group). Aiming to collect safety and performance data, both groups were provided with questionnaires during 6 consecutive visits (120 days of follow-up). At last visit, absence of painful symptoms was reported by the 98.8% and the 100% of women in DL and PL groups, respectively. Moreover, no nipple fissures were observed and no adverse events directly correlated to use of the device were reported. According to these findings, it can be concluded that Silver Cap<sup>®</sup> is a safe and effective device for nipple pain and fissure prevention. .
