TY - JOUR
T1 - Treatment with silver nitrate versus topical steroid treatment for umbilical granuloma
T2 - A non-inferiority randomized control trial
AU - Ogawa, Chikako
AU - Sato, Yoshiaki
AU - Suzuki, Chiyo
AU - Mano, Azusa
AU - Tashiro, Atsushi
AU - Niwa, Takafumi
AU - Hamazaki, Sayako
AU - Tanahashi, Yoshihiro
AU - Suzumura, Midori
AU - Hayano, Satoshi
AU - Hayakawa, Masahiro
AU - Tsuji, Takeshi
AU - Hoshino, Shin
AU - Sugiyama, Yuichiro
AU - Kidokoro, Hiroyuki
AU - Kawada, Jun ichi
AU - Muramatsu, Hideki
AU - Hirakawa, Akihiro
AU - Ando, Masahiko
AU - Natsume, Jun
AU - Kojima, Seiji
N1 - Publisher Copyright:
© 2018 Ogawa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2018/2
Y1 - 2018/2
N2 - Objective The aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma. Methods An open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The healing rate was evaluated until completion of 3 weeks of treatment. Results Participants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104) or topical steroid ointment (n = 103). Healing rates after 2 weeks of treatment were 87.5% (91/104) in the silver nitrate cauterization and 82% (82/100) in the topical steroid ointment group group. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%), indicating that the non-inferiority criterion was not met. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 [90.4%] vs. 91/100 [91.0%]; 0.6% [-13.2 to 14.3]). No major complications occurred in either group. Conclusions This study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. To clarify non-inferiority, a larger study is needed.
AB - Objective The aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma. Methods An open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The healing rate was evaluated until completion of 3 weeks of treatment. Results Participants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104) or topical steroid ointment (n = 103). Healing rates after 2 weeks of treatment were 87.5% (91/104) in the silver nitrate cauterization and 82% (82/100) in the topical steroid ointment group group. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%), indicating that the non-inferiority criterion was not met. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 [90.4%] vs. 91/100 [91.0%]; 0.6% [-13.2 to 14.3]). No major complications occurred in either group. Conclusions This study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. To clarify non-inferiority, a larger study is needed.
UR - http://www.scopus.com/inward/record.url?scp=85042024537&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85042024537&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0192688
DO - 10.1371/journal.pone.0192688
M3 - Article
C2 - 29438425
AN - SCOPUS:85042024537
SN - 1932-6203
VL - 13
JO - PloS one
JF - PloS one
IS - 2
M1 - e0192688
ER -