Evaluation of the Efficacy of 99.9% Pure Silver Trilaminate Cups in the Prevention and Treatment of Nipple Pain and Fissures

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Open Journal of Nursing, 2023, 13, 686-698
https://www.scirp.org/journal/ojn
ISSN Online: 2162-5344
ISSN Print: 2162-5336
DOI:
10.4236/ojn.2023.1310045 Oct. 25, 2023 686 Open Journal of Nursing
Evaluation of the Efficacy of 99.9% Pure Silver
Trilaminate Cups in the Prevention and
Treatment of Nipple Pain and Fissures
Monica Pilloni1, Pierina Zedda2, Carla Orrù3, Elena Fassina4, Maria Carmela Forte5,
Rossana Mazzulla6, Brunella Celestino7, Maria Francesca Marotto1, Manuela Neri8,
Gian Benedetto Melis9, Anna Maria Paoletti9
1University Hospital of Cagliari (UHC), Cagliari, Italy
2Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
3Maternal and Child Family Counselling, Quartu Sant’Elena, Cagliari, Italy
4Caruso’s Medical Office, Cusago, Italy
5Hospital of Castrovillari, Cosenza, Italy
6Hospital of Cosenza, Cosenza, Italy
7Maternal and Child Family Counselling, Argentano, Cosenza, Italy
8Company of National Importance and High Specialization (CNIHS) Giovanni Brotzu, Cagliari, Italy
9Women’s Wellness Foundation, Cagliari, Italy
Abstract
Breastfeeding is drastically decreasing over time and nipple trauma consti-
tutes one of the most significant reasons for its discontinuation. In this con-
text, this study aimed at evaluating the effectiveness and tolerability of a topi-
cal treatment device, namely Silver Cap®
(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 protec-
tion and creating a moist environment. The study involved 187 women:
38
started to apply the device prior to lactation (PL group) and 149 during lacta-
tion (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 visi
t, absence of painful symptoms was reported by the
98.8% and the 100% of women in DL and PL groups, respec
tively. 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 con-
cluded that Silver Cap® is a safe and effective device for nipple pain and fis-
sure prevention.
Keywords
Silver Cap, Breastfeeding, Breast Pain, Nipple Fissures
How to cite this paper:
Pilloni, M.,
Zedda,
P
., Orrù, C., Fassina, E., Forte, M.C., Maz-
zulla, R
., Celestino, B., Marotto, M.F.,
Neri,
M
., Melis, G.B. and Paoletti, A.M. (2023
)
Evaluation of the Efficacy of 99.9% Pure
Silver Trilaminate Cups in the Prevention
and Treatment of Nipple Pain and Fissures.
Open Journa
l of Nursing
,
13
, 686-698.
https:
//doi.org/10.4236/ojn.2023.1310045
Received:
September 11, 2023
Accepted:
October 22, 2023
Published:
October 25, 2023
Copyright © 20
23 by author(s) and
Scientific
Research Publishing Inc.
This work is licensed under the Creative
Commons Attribution International
License (CC BY
4.0).
http://creativecommons.org/licenses/by/4.0/
Open Access

M. Pilloni et al.
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10.4236/ojn.2023.1310045 687 Open Journal of Nursing
1. Introduction
In the past decades, a substantial amount of evidence has been collected on the
beneficial effects that exclusive breastfeeding has on both mothers and children.
Just to mention a few, breastfeeding has been associated to the improvement of
children survival, health, and development, as well as to the prevention of breast
and ovarian cancer and diabetes in mothers [1] [2]. Accordingly, recommen-
dations of World Health Organization state that infants should be exclusively
breastfed for the first 6 months of life and thereafter, complementary foods should
be introduced while continuing to breastfeed for up to 2 years and beyond [3]
[4].
Despite its vital role for children and mothers’ health, global target for exclu-
sive breastfeeding remains unmet. Such below-standard rates can be ascribed to
multiple factors, spanning from sociocultural to market determinants, which in-
fluence mothers’ decisions [5]. In addition to these environmental components,
several medical reasons might also play a role. Among them, nipple pain and
fissures represent some of the leading causes of early breastfeeding cessation [6]
[7] [8] [9] [10].
Nipple fissures can be described as a macroscopic cutaneous lesion around the
nipple and areola, typically arising during the first post-partum week as ulcera-
tions, oedema, erythema, blisters, and dark spots [11]. Such lesions and the asso-
ciated pain are experienced by about the 80% - 90% of breastfeeding women [12]
[13]. And the main causes of their occurrence have a mechanical, infectious or
hormonal origin [2] [14]. Indeed, incorrect latch and positioning of infants can
lead to nipple damage, eventually facilitating bacterial infections (usually
Sta-
phylococcus aureus
and
Candida albicans
). Moreover, hormonal changes asso-
ciated to menstrual cycle can also contribute to nipple soreness [2].
As the surface of the skin is covered by a hydrophilic film which ensures the
maintenance of the correct pH and hydration of the stratum corneum, a proper-
ly moisturized areola prevents the onset of skin damage, nipple fissures, soreness
and mastitis [15]. Accordingly, the prevention and treatment of nipple fissures
relies, from one side, on appropriate mothers training regarding the correct po-
sitioning and latching of the infant and, from the other side, on the application
of topical treatments including hydrogels, warm compresses, collagenase, and
dexpanthenol [12] [16] [17]. Lanolin, breast milk and hydrogel dressing are con-
sidered valid interventions to create a moist healing environment to prevent and
treat nipple fissures and sorenesss [16] [17] [18].
The effects of moisture on epidermal regeneration include enhanced kerati-
nocyte migration, proliferation, and differentiation, as well as increased fibrob-
last proliferation, collagen synthesis, angiogenesis, and a subsequent faster wound
healing process. Nevertheless, the optimal level of moisture has not been clearly
defined [19] [20]. Accordingly, occlusive dressings (
i.e.
, gels, films) [17] create a
hypoxic environment that improves collagen synthesis and angiogenesis, thus
accelerating re-epithelization, and act as a barrier preventing infections that

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could delay wound healing [21]. However, adverse events such as burning, itch-
ing, and fissure infection have been associated to the use of lanolin [18] [21] and,
while safe, breast milk typically requires long times to provide visible results [12]
[17] [22]. Some difficulties have also been associated to the use of hydrogel and
hydrocolloid dressings. Specifically, hydrogels can cause the maceration of the
wound, resulting in bacterial overgrowth, and hydrocolloids removal can be un-
pleasant due to the exudate and hydrocolloids mix malodor [21].
An alternative approach to create a moist and hypoxic environment is repre-
sented by the use of 99.9% pure silver trilaminate cups—marketed as Silver Cap®
(Depofarma S.P.A., Mogliano Veneto, Italy)—to be placed on the nipple [23].
Besides providing physical protection as breast shells, such cups create a moist
area around the nipple, boosting wound epithelialization [24].
The safety and effectiveness of Silver Cap® device in treating nipple fissures
have been already proven in an observational prospective study, providing en-
couraging results [23]. With the aim of expanding such previous findings, in the
current study, the effectiveness and tolerability of Silver Cap® have been investi-
gated from the perspective of preventing nipple fissure formation, focusing on
the importance of creating a healthy and elastic nipple tissue to prevent skin
damages [25].
For this purpose, Silver Cap® performances were evaluated on healthy women
who started to apply the device either prior to start lactating or in the early lac-
tating period.
2. Subjects and Methods
This study involved 38 women who started to apply the Silver Cap® device at 35
weeks of gestation (prior to lactation group, PL) and 149 women whose treat-
ment started within 7 days from childbirth (during lactation group, DL). None
of the patients reported nipple fissures at the day of enrollment. In accordance
with our institution regulations, ethical approval was not sought since the data
were the result of doctors’ databases and patient-reported questionnaires, not
including subject identifying or sensitive data. Nevertheless, ethical considera-
tions were made with respect to the principles for research on human subjects as
outlined in the Declaration of Helsinki.
PL women underwent the first visit (V0) at 35 weeks of gestation, while DL
women underwent V0 on the day of delivery. At such first visit, all patients were
instructed to use the device correctly.
Both groups were provided with questionnaires during 6 consecutive visits,
scheduled at 7, 15, 30, 60, 90, and 120 days after delivery (from now on V7, V15,
V30, V60, V90, and V120). Specifically, at each visit women were asked to rate
the experienced nipple pain with a 4-point scale (from 0 to 3) of increasing pain
levels (no pain, mild, moderate, severe). The questionnaire was designed to col-
lect information also regarding: occurrence of nipple fissure, lactation modality
(either exclusively breastfeeding or not), device usage frequency (never, occa-

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sionally, always, only in case of painful symptoms), and occurrence of adverse
events (frequency and type).
During V7, only women belonging to the PL group were also asked to report
on how many hours per day during pregnancy (from week 35 of gestation to
week 40) they were accustomed to use the device and to describe possible skin
changes around the nipple area (no skin changes, softer, softer and more elastic,
harder, thicker, thinner).
Statistical Analysis
Data analyses was conducted using SAS 9.4 (SAS Institute Inc., Cary, NC, USA).
At each evaluated timepoint, frequency distribution of categorical variables was
evaluated as count and percentage. Continuous variables were analyzed as count,
mean, and interquartile range (IQR).
For categorical variables, differences between patient’s groups (
i.e.
, PL and
DL) were tested for significance using the Fisher’s exact test. For each patient’s
group, categorical variable changes at different timepoints were tested using the
McNemar test. Normality test was carried out for continuous variables by means
of Shapiro-Wilks test. All tests were two-tailed and considered significant at a
5% level.
3. Results
3.1. Nipple Pain
To perform the statistical evaluations, pain scores reported by patients were
pooled in two levels: level “0 - 1” (No pain/Mild) and level “2 - 3” (Moderate/
Severe). Frequency distribution of nipple pain level divided by patient group and
timepoint of evaluation are reported in Table 1. Overall, all patients reported a
decreasing pain level from V7 to V120. As also graphically represented in Figure
1, between treatment groups comparison showed a significant (p = 0.04) lower
proportion of Moderate/Severe pain in favor of the PL group, both at V7 (26.3%
vs 45.6%) and V15 (7.9% vs 22.8%). Conversely, no significant differences in the
PL and DL group were reported at V30 and for all the subsequent evaluated
timepoints (
i.e.
, V60, V90, and V120).
The analysis of pain level changes at different timepoints showed that 7 out of
10 patients of the PL group with Moderate/Severe pain at V7 switched to a No
pain/Mild level of pain at V15 (Table 2). Moreover, none of the 28 patients re-
porting a No pain/Mild score at V7 switched to the higher pain level (p = 0.008).
For the PL patients, no further significant pain level changes were observed from
V30 to V120 (p > 0.05). Concerning the DL group (Table 3), a significant pro-
portion of patients switched to a lower level of pain at V15 (55.9%; p < 0.001),
V30 (78.8%; p < 0.001), and V60 (77.8%; p = 0.03).
3.2. Nipple Fissures
All the data regarding the frequency distribution of nipple fissures occurrence

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divided by patient group and timepoint of evaluation are reported in Table 4. As
also shown in Figure 2, nipple fissures mostly affected DL patients (p < 0.001).
Indeed, in the PL group, only one patient (2.6%) reported nipple fissures at V7
which resolved within V15. Starting from 30 days on from delivery, the observed
proportion of patients reporting fissures were no longer significantly different
between patients’ groups and, at the last visit, no fissures were observed in none
of the examined groups. Focusing on DL patients, nipple fissures significantly (p
< 0.001) healed within 30 days from delivery (Table 5). Specifically, 27 patients
Table 1. Frequency distribution of nipple pain level divided by patient group and time-
point of evaluation.
Patient group, N (%)
Visit
Pain levela
PL
DL
p-value
V7 0 - 1 28 (73.7) 81 (54.4)
0.04
2 - 3 10 (26.3) 68 (45.6)
V15 0 - 1 35 (92.1) 115 (77.2)
0.04
2 - 3 3 (7.9) 34 (22.8)
V30 0 - 1 36 (97.3) 137 (93.2) 0.70
2 - 3 1 (2.7) 10 (6.8)
V60 0 - 1 35 (100) 129 (97.7) 1.00
2 - 3 0 3 (2.3)
V90 0 - 1 28 (100) 102 (99.0) 1.00
2 - 3 0 1 (1.0)
V120 0 - 1 23 (100) 80 (98.8) 1.00
2 - 3 0 1 (1.2)
a. 0 - 1 = No pain/Mild; 2 - 3 = Moderate/Severe.
Table 2. Frequency distribution of pain level changes at different visits in the PL group.
Pain levela at V2, N (%)
V1, V2
Pain levela at V1
0 - 1
2 - 3
p-value
7, 15 0 - 1 28 (100) 0
0.008
2 - 3 7 (70.0) 3 (30.0)
15, 30 0 - 1 34 (100) 0 0.16
2 - 3 2 (66.7) 1 (33.3)
30, 60 0 - 1 34 (100) 0 -
2 - 3 1 (100) 0
60, 90 0 - 1 28 (100) 0 -
2 - 3 0 0
90, 120 0 - 1 23 (100) 0 -
2 - 3 0 0
a. 0 - 1 = No pain/Mild; 2 - 3 = Moderate/Severe.

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Figure 1. Frequency distribution of nipple pain level divided by patient group at V7 and
V15.
Table 3. Frequency distribution of pain level changes at different visits in the DL group.
Pain levela at V2, N (%)
V1, V2
Pain levela at V1
0 - 1
2 - 3
p-value
7, 15 0 - 1 77 (95.1) 4 (4.9)
<0.001
2 - 3 38 (55.9) 30 (44.1)
15, 30 0 - 1 111 (97.4) 3 (2.6)
<0.001
2 - 3 26 (78.8) 7 (21.2)
30, 60 0 - 1 121 (99.2) 1 (0.8)
0.03
2 - 3 7 (77.8) 2 (22.2)
60, 90 0 - 1 101 (100) 0 0.32
2 - 3 1 (50.0) 1 (50.0)
90, 120 0 - 1 80 (100) 0 -
2 - 3 0 1 (100)
a. 0 - 1 = No pain/Mild; 2 - 3 = Moderate/Severe.
Table 4. Frequency distribution of nipple fissures divided by patient group and timepoint
of evaluation.
Patient group, N (%)
Visit
PL
DL
p-value
V7 1 (2.6) 43 (28.9)
<0.001
V15 0 19 (12.8)
0.02
V30 0 6 (4.1) 0.60
V60 0 3 (2.7) 1.00
V90 0 2 (1.9) 1.00
V120 0 0 -

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Table 5. Frequency distribution of nipple fissures presence at different timepoints in the
DL group.
Fissures at V2, N (%)
V1, V2
Fissures at V1
Absent
Present
p-value
7, 15 Absent 103 (97.2) 3 (2.8)
<0.001
Present 27 (62.8) 16 (37.2)
15, 30 Absent 128 (99.2) 1 (0.8)
0.001
Present 13 (72.3) 5 (27.8)
30, 60 Absent 125 (99.2) 1 (0.8) 0.18
Present 4 (66.7) 2 (33.3)
60, 90 Absent 98 (98.0) 2 (2.0) 0.65
Present 3 (100) 0
90, 120 Absent 78 (100) 0 -
Present 2 (100) 0
a. 0 - 1 = No pain/Mild; 2 - 3 = Moderate/Severe.
Figure 2. Frequency distribution of nipple fissures divided by patient group at V7 and
V15.
(62.8%) healed within V15 and 13 patients (72.3% of the 18 left at V15) healed at
V30.
3.3. Lactation Modality
Data regarding lactation modality (either exclusively breastfeeding or not) dur-
ing treatment are reported in Table 6. On average, the proportion of patients
exclusively breastfeeding, slightly decreased from V7 (81.6%, PL group; 85.8%,
DL group) to V120 (69.6%, PL group; 76.5%, DL group) in both evaluated groups.
Such proportions were not significantly different when comparing the two pa-
tients’ groups at any evaluated timepoint.

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Table 6. Frequency distribution of exclusive breastfeeding divided by treatment arm and
timepoint.
Patient group, N (%)
Visit
PL
DL
p-value
V7 31 (81.6) 127 (85.8) 0.61
V15 31 (81.6) 123 (82.6) 1.00
V30 31 (81.6) 117 (80.7) 1.00
V60 27 (77.1) 104 (78.2) 1.00
V90 22 (78.6) 83 (79.8) 1.00
V120 16 (69.6) 62 (76.5) 0.59
3.4. Device Usage Frequency
Both patients’ groups, were asked to always use the device until V15. Frequency
distributions of device usage from V30 on are reported in Table 7 divided by
patients’ group. From V30 to V90, the majority of patients in both evaluated
groups reported to always use the device without statistically significant differ-
ences between groups (p > 0.05 at V30, V60, and V90). Differently, at V120,
there was a significantly (p = 0.01) different distribution with most of the PL pa-
tients reporting “never” (56.5%) and most of the DL patients (52.5%) reporting
“always”.
Regarding PL patients, they were also asked to report on device usage during
pregnancy (hours/day). PL patients resorted to the use of the device from a
mean of 6.0 hours/day (IQR 0.12) at week 35 of gestation to a maximum average
of 13.3 hours/day (IQR 7.23) at week 39. Overall, from week 35 of gestation to
week 40, PL patients used the device for an average time of 10.3 hours/day (IQR
5.14).
3.5. Skin Changes Associated to the Use of the Device
At V7, patients belonging to the PL group were asked to report on possible nip-
ple skin changes associated to the use of the device during pregnancy (Table 8).
The two most prevalent nipple changes were classified as “softer” (52.6%) and
“softer and more elastic” (29.0%). In 4 patients (10.5%), no skin changes were
observed, while only 1 patient (2.6%) per category reported either “harder”,
“thicker”, or “thinner” skin.
3.6. Adverse Events and Drop-Out Frequency
None of the PL patients reported the occurrence of adverse events (AEs). As re-
gards the DL group, 2 patients reported nipples irritation at V7 which might be
ascribed to lactation
per se
. In addition, 4 patients started to suffer from mastitis,
event that cannot be directly related to device usage though. Indeed, other fac-
tors might have contributed to the occurrence of mastitis: 2 patients concomi-
tantly used topical gels; in 1 patient, mastitis started right after changing lactation

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Table 7. Frequency distributions of device usage divided by patient group and timepoint.
Patient group, N (%)
Visit
PL
DL
p-value
V30
Never 0 16 (10.7)
0.08
Occasionally 6 (15.8) 18 (12.1)
Always 32 (84.2) 109 (73.2)
Only in case of pain 0 6 (4.0)
V60
Never 6 (17.1) 19 (14.4)
0.56
Occasionally 3 (8.6) 23 (17.4)
Always 24 (68.6) 78 (59.1)
Only in case of pain 2 (5.71) 12 (9.1)
V90
Never 7 (25.0) 24 (23.1)
0.62
Occasionally 8 (28.6) 22 (21.2)
Always 13 (46.4) 52 (50.0)
Only in case of pain 0 6 (5.8)
V120
Never 13 (56.5) 21 (26.3)
0.01
Occasionally 5 (21.7) 12 (15.0)
Always 5 (21.7) 42 (52.5)
Only in case of pain 0 5 (6.3)
Table 8. Frequency distribution of nipple skin changes reported by PL patients at V7.
Skin change
N (%)
No skin change 4 (10.5)
Softer 20 (52.6)
Softer and more elastic 11 (29.0)
Harder 1 (2.6)
Thicker 1 (2.6)
Thinner 1 (2.6)
modality (from exclusively breastfeeding to mixed modality); in the last patient,
mastitis started after device usage discontinuation.
All the patients underwent all visits until V30. At last follow-up visit (V120),
study population consisted of 24 PL patients and 83 DL patients (63.2% and
55.7% of the enrolled patients at V0, respectively).
4. Discussion
As it is well known, breastfeeding gives many advantages for both mother and
child [26] [27] [28]. Nevertheless, most of mothers reporting episodes of nipple
pain and fissures feel compelled to stop breastfeeding prematurely [16] or delay
seeking treatment until substantial damage has already occurred [25].

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In this context, our study aimed to collect data regarding nipple soreness and
fissures occurrence rate in women using Silver Cap® from the 35th week of
pregnancy or starting the treatment during breastfeeding, as a way to under-
stand if the early promotion of nipple hydration might represent an efficient
preventive strategy.
Results of the present study suggest that Silver Cap® can be safely and effec-
tively employed as a device to prevent nipple pain and fissure formation in lac-
tating women and that the best clinical outcomes are obtained when an early ap-
plication of the device (
i.e.
, during the last period of pregnancy) is advised.
The preventive action of the device is supported by the comparison of the oc-
currence rates observed in the current study with respect to the prevalence data
reported in literature regarding both nipple pain (45.6% as the highest percen-
tage observed in the DL group vs 79% - 97% reported in literature) and nipple
damage (28.9% as the highest percentage observed in the DL group vs 26.7% -
52.75% reported in literature) [29] [30] [31].
When comparing the DL patients’ data to the ones reported in literature is
worth noticing that the resulting percentages might have been biased by the fact
that women belonging to the DL group started to apply the device within 7 days
after delivery and thus, some of them were possibly not benefiting from the ap-
plication of the device yet. As a consequence, a significant improvement of DL
patients’ symptoms was clearly observed after 15 days from delivery. Specifically,
at V15, the percentage of DL patients reporting pain dropped to 22.8% and nip-
ple fissure were found in the 12.8% of DL patients. Differently, in the PL group,
percentages as low as 26.3% and 2.6% of nipple pain and fissures, respectively,
were already achieved at V7, after 15 days from delivery none of the PL patients
reported nipple fissure and only the 7.9% complained about nipple pain. There-
fore, when comparing symptoms’ occurrence rate of the two groups, more fa-
vorable results were observed in the PL group. However, such comparison should
be interpreted within the limitation of having substantially different sample siz-
es, which might have led to the observation of more favorable results in the
smaller group (
i.e.
, PL group).
Overall, all evaluated symptoms decreased along with the weeks of treatment
in both groups. At last follow-up (120 days), none of the patients suffered from
nipple fissures and only 1 DL patient (1.2%) still reported painful symptoms.
Moreover, hinting at the safety of the device, none of the few reported adverse
events (occurring in 6 DL patients out of 149 [4.0%]) was undoubtedly corre-
lated to the use of the device.
Taking into account that PL and DL group did not significantly differ neither
in term of breastfeeding modality or in frequency of device usage, the better
clinical outcomes observed in the PL group with respect to the DL group might
be attributed to the nipple skin changes experienced by PL patients. Indeed, the
majority of PL patients reported to feel the skin around the nipple as “softer”
(52.6%) and “softer and more elastic” (29.0%) after using the device during the
pre-partum period. Such skin changes might have played a crucial role in pre-

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paring the nipple area to breastfeeding, eventually preventing the occurrence of
nipple pain and fissures.
Therefore, together with the findings of a previously conducted study [23], the
results herein discussed indicate that Silver Cap® device serves as a safe and ef-
fective strategy to treat and prevent nipple pain and fissure formation in lactat-
ing women.
Main limitations of the study are represented by the lack of a control group
and the small number of patients in the PL group. Moreover, in the interest of
sensitive data protection, patients’ demographic data were not collected and
thus, homogeneity of baseline characteristics between groups was not assessed.
As a future perspective, it would be interesting to confirm the encouraging re-
sults obtained in the PL group with a larger controlled study.
5. Conclusion
Results of the present study suggest that Silver Cap® is a safe and effective device
for the prevention of nipple pain and fissure formation and that the most rele-
vant clinical outcomes are obtained when applying the device during the last pe-
riod of pregnancy. Indeed, after 120 days of treatment, the absence of painful
symptoms was reported by the 100% and the 98.8% of women who started to use
the device prior to and during the lactation period, respectively. Notably, no
nipple fissures were observed and no adverse events directly correlated to use of
the device were reported.
Conflicts of Interest
The authors declare no conflicts of interest regarding the publication of this pa-
per.
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