title: Evaluation of the effectiveness of a silver-impregnated medical cap for topical treatment of nipple fissure of breastfeeding mothers.
abstract: 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.
  
  
  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.
authors.affiliation: 1 Gynecologic and Obstetric Clinic, Department of Surgical, Microsurgical, and Medical Sciences, Sassari University , Sassari, Italy .
authors.forename: Adriano
authors.initials: A
authors.lastname: Marrazzu
authors.affiliation: 2 Neonatal Intensive Care Unit, Sassari University , Sassari, Italy .
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Sanna
authors.affiliation: 1 Gynecologic and Obstetric Clinic, Department of Surgical, Microsurgical, and Medical Sciences, Sassari University , Sassari, Italy .
authors.forename: Francesco
authors.initials: F
authors.lastname: Dessole
authors.affiliation: 1 Gynecologic and Obstetric Clinic, Department of Surgical, Microsurgical, and Medical Sciences, Sassari University , Sassari, Italy .
authors.forename: Giampiero
authors.initials: G
authors.lastname: Capobianco
authors.affiliation: 1 Gynecologic and Obstetric Clinic, Department of Surgical, Microsurgical, and Medical Sciences, Sassari University , Sassari, Italy .
authors.forename: Maria Domenica
authors.initials: MD
authors.lastname: Piga
authors.affiliation: 1 Gynecologic and Obstetric Clinic, Department of Surgical, Microsurgical, and Medical Sciences, Sassari University , Sassari, Italy .
authors.forename: Salvatore
authors.initials: S
authors.lastname: Dessole
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001942:Breast Feeding / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D009035:Mothers; D009558:Nipples / Q000187:drug effects* / Q000293:injuries; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D017060:Patient Satisfaction; D011482:Protective Devices; D018030:Silver Compounds / Q000008:administration & dosage*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D018030:Silver Compounds