摘要
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. .
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. .
作者
Monica Pilloni
Pierina Zedda
Carla Orrù
Elena Fassina
Maria Carmela Forte
Rossana Mazzulla
Brunella Celestino
Maria Francesca Marotto
Manuela Neri
Gian Benedetto Melis
Anna Maria Paoletti
Monica Pilloni;Pierina Zedda;Carla Orrù;Elena Fassina;Maria Carmela Forte;Rossana Mazzulla;Brunella Celestino;Maria Francesca Marotto;Manuela Neri;Gian Benedetto Melis;Anna Maria Paoletti(University Hospital of Cagliari (UHC), Cagliari, Italy;Department of Surgical Sciences, University of Cagliari, Cagliari, Italy;Maternal and Child Family Counselling, Quartu Sant’Elena, Cagliari, Italy;Caruso’s Medical Office, Cusago, Italy;Hospital of Castrovillari, Cosenza, Italy;Hospital of Cosenza, Cosenza, Italy;Maternal and Child Family Counselling, Argentano, Cosenza, Italy;Company of National Importance and High Specialization (CNIHS) Giovanni Brotzu, Cagliari, Italy;Women’s Wellness Foundation, Cagliari, Italy)
