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Use of a Hydrocolloid Dressing in the Prevention of Device-related

Pressure Ulcers During Noninvasive Ventilation: A Meta-analysis of
Randomized Controlled Trials

Article  in  Wound Management & Prevention · February 2019

DOI: 10.25270/wmp.2019.2.3038

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Empirical Research

Use of a Hydrocolloid Dressing in the

Prevention of Device-related Pressure
Ulcers During Noninvasive Ventilation:
A Meta-analysis of Randomized Controlled Trials
Ji-Yu Cai, BS; Man-Li Zha, BS; and Hong-Lin Chen, MD

e
ABSTRACT
Use of a hydrocolloid dressing (HCD) is generally recommended to help prevent pressure ulcers (PUs) in high-risk patients,

at
including ulcers caused by noninvasive ventilation (NIV). PURPOSE: The study was conducted to compare the effect of pre-
ventive use of HCD to other methods in the rate of facial PUs caused by NIV. METHODS: PubMed, Web of Science, China
National Knowledge Infrastructure, and Wanfang Data were searched from date of index inception to August 2018 without

lic
language restrictions to identify randomized controlled trials (RCTs) that compared HCD use to other NIV-related PU preven-
tion measures. Publications were systematically reviewed, data were extracted, and study quality was assessed using the Jadad
scale. Odds ratio (OR) with 95% confidence intervals (CIs) for PU incidence in patients using HCD versus patients managed with
gauze or standard skin care procedures (control) were calculated using a fixed-effects model. RESULTS: The search yielded
up
80 publications; 40 met the study criteria for full-text and 22 met the meta-analysis inclusion criteria (total study participants
= 2519). Patients who used a HCD (n = 1260) had a significantly decreased incidence of PU (OR = 0.15; 95% CI: 0.11-0.20) com-
pared with control group patients (n = 1259). Subgroup analysis by age showed a lower incidence in children (OR = 0.09; 95%
CI: 0.01-0.81) and adults (OR = 0.16; 95% CI: 0.12-0.22) in the HCD group than in the control group. PU incidence using HCD was
lower compared to gauze (OR = 0.17; 95% CI: 0.10-0.28) and regular skin care (OR = 0.13; 95% CI: 0.09-0.19). Funnel plot diagrams
D
suggested a risk of bias. Sensitivity analysis using a random-effects model did not change the result of the main meta-analysis.
CONCLUSION: Using a HCD significantly decreased the incidence of facial PUs caused by NIV. Additional high-quality, prospec-
tive research to confirm the effectiveness of HCD in preventing NIV-related PUs is warranted.
ot

KEYWORDS: meta-analysis, noninvasive ventilation, complication, pressure ulcer, hydrocolloid dressing

INDEX: Wound Management & Prevention 2019;65(2):30–38 doi: 10.25270/wmp.2019.2.3038

N

POTENTIAL CONFLICTS OF INTEREST: This study was funded by the Postgraduate Research & Practice Innovation Program
of Jiangsu Province, PR China (KYCX18_2430).
o

The latest guidelines from the Na- equipment (including respiratory de- According to retrospective, cohort re-
1 4-6
D

tional Pressure Ulcer Advisory Panel
(NPUAP) include medical device-relat-
ed pressure ulcers (PUs), defined as a
localized injury to the skin or underly-
ing tissue as a result of sustained pres-
sure from a medical device, and muco-
sal membrane pressure ulcers as pressure
1
injury categories. Medical device-relat-
ed PUs differ from classic PUs in that
they are caused by essential therapeutic
vices), occur in both the skin and mu-
cous membranes, and do not usually
2
lie over a bony prominence. Medical
device-related PUs are part of hospi-
tal-acquired PU evaluation.
Noninvasive ventilation (NIV) is the
application of positive pressure via the
upper respiratory tract in order to aug-
ment alveolar ventilation and provide
3
respiratory support without intubation.
search and literature review, the ad-
vantages of NIV compared with invasive
ventilation include a lower incidence
of upper airway injury, lower mortality
rates, fewer instances of laryngeal steno-
sis and nosocomial pulmonary infection,
a decreased need for sedative or paralytic
drugs, and fewer lengthy hospital stays.
7,8
As shown in 2 review studies, use of
this technology has grown exponentially,

Ms. Cai and Ms. Zha are graduate students; and Dr. Chen is a professor, School of Nursing, Nantong University, Nantong City, Jiangsu Province, PR
China. Please address correspondence to: Hong-Lin Chen, MD, School of Nursing, Nantong University, Nantong City, Jiangsu Province, PR China: email:
honglinyjs@126.com.

30 February 2019  |  vol. 65, no. 2

Cai et al
and it has become an integral tool in the
treatment of acute and chronic respi-
ratory failure. Use of NIV initially was
restricted to intensive care units and
respiratory medicine wards; according
9
to a randomized controlled trial (RCT),
it now is used for care provided before
the patient enters the hospital, includ-
ing home management of patients with
chronic conditions.
PUs are a common complication of
NIV. In a prospective, longitudinal obser-
10
vational study that analyzed 51 patients
with noninvasive positive pressure ven-
tilation, 31 patients developed PUs, rep-
resenting a cumulative incidence rate of
11
60.8%. A before-after comparison study
conducted in 5 intensive care units at
a university-affiliated medical center
showed PUs developed in 20% of patients
that used nasal-oral masks and in 2% that
used full-masks. In a cross-sectional ret-
12
rospective study (N = 40), the incidence
of facial skin injury in children was 48%.
The development of PUs is associated
with adverse outcomes that may con-
tribute to patient pain and suffering, im-
paired quality of life, prolonged hospital
13-15
stay, and increased hospital costs.
Prevention usually is considered the
most efficient method to address PUs
ot
16
caused by NIV. The NPUAP recom-
mends using wound dressings such as
transparent film, silicone, thin foam,
N
or hydrocolloid to reduce friction and
17
shear to prevent PU. Weng conduct-
ed a quasi-experimental study (N = 90)
to compare the efficacy of protective
o
dressings (Tegasorb and Tegaderm; 3M,
St Paul, MN) versus using no materials
D
for PU prevention in patients with NIV.
The incidence of PU among the 3 groups
was 0.4, 0.533, and 0.967, respectively (P
<.01). The study showed the potential
protective effect of hydrocolloid dress-
ings on facial PUs caused by NIV. Re-
18
sults of a prospective controlled study
indicated use of hydrocolloid dressings
decreased the incidence of nasal trau-
ma in preterm infants with NIV, possi-
bly because the mask was sealed so as
to reduce excessive pressure. However,
hydrocolloid dressing use to prevent
PUs caused by NIV remains contro-
19
versial. Riquelme et al constructed a
www.woundmanageprevent.com
simulated model of NIV that showed
an inability of the hydrocolloid dress-
ing to reduce facial pressure, leading
the authors to conclude hydrocolloid
dressings did not help prevent PUs in
patients with NIV.
The aim of this systematic review was
to determine the effectiveness of hydro-
colloid dressing use in the prevention of
facial PUs caused by NIV.
METHOD
Search strategy. PubMed, Web of
Science, China National Knowledge
Infrastructure, and Wanfang Data were
at
searched for RCTs published from date
of index inception until August 2018
using the terms pressure ulcer, pressure
lic
injury, pressure sore, bedsore, decubitus,
noninvasive, ventilation, dressing, hy-
drocolloid, and water colloid. No search
restrictions were imposed related to
up
country, language, or year of publica-
tion. The reference lists from retrieved
articles also were searched to obtain ad-
ditional studies.
Inclusion and exclusion criteria.
D
This systematic review only included
studies where a hydrocolloid dressing
was used as the prevention variable
for PU in patients with NIV. Other in-
clusion criteria were: the study was an
RCT, the objective was assessing the
effectiveness of a hydrocolloid dress-
ing (regardless of brand) in preventing
facial PU, the intervention comparison
involved a hydrocolloid dressing versus
a control, and the outcome was the in-
cidence of facial PUs. Studies were ex-
cluded if the number of patients devel-
oping PUs or the incidence of PUs was
not reported; duplicate publications or
duplicate reporting of patient cohorts
also were excluded.
Data extraction. The following data of
eligible publications were collected: first
author, publication year, study design,
country, sample size, participant age,
preventive intervention (the control was
use of regular skin care or gauze dress-
ings), PU incidence, and PU stage. The
information was extracted independent-
ly by 2 authors, and disagreement was
resolved by discussion and consensus
between them.
KEYPOINTS
• Pressure ulcers (PUs) second-
ary to noninvasive ventilation
(NIV) are a common, painful,
and costly complication.
• To examine if the use of hydro-
colloid dressings (HCD) is an
effective method to prevent
these ulcers, the authors con-
ducted a meta-analysis of 20
e
published randomized con-
trolled clinical studies (n = 2519
patients, 368 PUs).
• In the total sample as well as in
different age groups, the risk
of developing an NIV-related
PU was significantly lower in
the HCD than in the control
(gauze dressings or regular
skin care) group.
• Because the overall quality of the
studies was low, better designed
randomized controlled clinical
studies are needed to confirm
the results of this analysis.
20
Quality assessment. The Jadad scale
was used to assess the methodological
quality of all included studies. The tool
included randomized sequence genera-
tion, blinding, and loss of participants to
follow-up. Points were calculated as fol-
lows: a proper randomization and proper
blinding received 2 points each, report-
ing withdrawals and dropouts received 1
point. The total score of reviewed stud-
ies ranged from 0 to 5; a score <2 indicat-
ed poor methodological quality.
Statistical analysis. The primary
outcome analyzed was the incidence
of facial PUs caused by NIV in the hy-
drocolloid dressing and control group.
For analysis of the dichotomous vari-
ables (PU development), odds ratio
(OR) and 95% confidence interval (CI)
were reported for outcomes. Statisti-
cal heterogeneity was assessed using
χ² and inconsistency (I²) statistics. I²
>50% indicated significant heteroge-
neity and the results were interpreted
21
with caution. If no heterogeneity was
found, a fixed-effects model was used
31
Preventing facial pressure ulcers
ot
N
figure 1. Flow diagram of publication retrieval and inclusion.
o
for meta-analysis; otherwise, the DerSi-
monian and Laird random-effect model
22
D
was used. Overall effects were evaluat-
ed by the Z test. A 2-sided P value <.05
was considered statistically significant.
Publication bias was evaluated by fun-
nel plot. Asymmetry in funnel plots in-
dicated publication bias in meta-analy-
sis. Sensitivity analysis was performed
by changing the effect model. Subgroup
analyses were considered when the par-
ticipants were at different age levels or
used different control group interven-
tions. All statistical analyses were con-
ducted using Review Manager Software,
version 5.3 (Cochrane Collaboration,
Oxford, England).
32
at
lic
up
D
RESULTS
Results of document retrieval. A to-
tal of 80 publications were found; after
duplicates were removed, 58 studies re-
mained and of those, 18 were excluded
upon abstract review. After reviewing 40
full-text articles, 8 studies were excluded
because they were not randomized and
10 studies were excluded due to no avail-
able data (ie, the studies did not report
the number of patients who developed
PU or the incidence of PU in hydrocol-
loid dressing and control groups). The
23-44
remaining 22 studies were includ-
ed for analysis (see Figure 1), yielding
a total of 2519 patients, including 368
NIV patients with PUs. The number of
participants in the hydrocolloid dressing
and control groups was 1260 and 1259,
respectively; 67 PUs developed in the
hydrocolloid dressing and 301 developed
in the control group.
35,37,43
Participants in 3 studies were
children (maximum age 25 months),
23-34,36,38-42,44
and 19 studies included adult
and geriatric patients (minimum age
26
>19; 1 study did not specify exact adult
age). Participants in treatment groups
were provided hydrocolloid dressings
e
before putting on the NIV face masks.
Control group interventions included
gauze dressings or regular skin care; in
23,27,29,30,32-34,39,44
9 studies, gauze was ap-
plied to skin beneath the mask. In 13
24-26,28,31,35-38,40-43
studies no dressing mate-
rials were applied; clinicians of patients
who used NIV continuously for more
than 2 hours were instructed to relax
the headband, take off the mask for 10
to 15 minutes, keep the face clean and
dry, and observe the skin condition. Skin
care (keeping facial skin clean and dry,
relaxing the NIV strap regularly, main-
taining proper strap tightness, and ob-
serving the skin condition at intervals)
was used to prevent PU development.
27,31,38,42
In 4 studies, regular skin care in-
volved Comfeel dressings (Coloplast
Corp, Humlebaek, Denmark), and in 2
36,44
studies Algoplaque dressings (URGO
Company, Paris, France) were provided.
The table summarizes the characteris-
tics of the 22 studies assessed in the final
meta-analysis.
Main meta-analysis. The incidence of
PU caused by NIV was 5.31% in the hy-
drocolloid dressing group and 23.91% in
the control group. No heterogeneity was
found among the included studies (χ² =
23.63; P = 0.31; I² =1 1%). Using a fixed-ef-
fect model, the summary OR of patients
in hydrocolloid dressing group com-
pared with patients in the control group
was 0.15 (95% CI: 0.11–0.20; Z = 12.72; P
<.00001) (see Figure 2). The overall ef-
fect showed hydrocolloid dressing use
significantly decreased the development
of PUs in patients with NIV. Sensitivity
analysis using a random-effect mod-
el found the summary OR of patients
was 0.16 (95% CI: 0.11–0.22; Z = 10.9; P
<.00001). The sensitivity analysis did
February 2019  |  vol. 65, no. 2
 TABLE. SUMMARY OF INCLUDED STUDIES
HYDROCOLLOID
CONTROL GROUP
Cai et al

CONTROL GROUP
AUTHOR STUDY SAMPLE GENDER PU JADAD
COUNTRY AGE (YEARS) GROUP SAM-
(YEAR) DESIGN SIZE (M/ F) STAGE SAMPLE PU PU SCORE
INTERVENTION PLE
SIZE INCIDENCE INCIDENCE
SIZE
Wang23 (2014) China RCT
D 152 86/66 60-80 Gauze care 1-2 72 4.2% (3/72) 80 15.0% (12/80) 2

www.woundmanageprevent.com
24 a
Ding (2012) China RCT 100 N/A Mean 65 Regular skin care 1-2 50 8% (4/50) 50 38% (19/50) 2
Hu25 (2012) China RCT 65
o 38/27 19-65 Regular skin care 1-2 33 9.09% (3/33) 32 34.38% (11/32) 2
26 b
Fu (2014) China RCT 126 98/26 Geriatrics Regular skin care N/A 61 1.61% (1/61) 65 15.38% (10/65) 2
a
Zhang27 (2009) China RCT 57 N/A Mean 67.5 Gauze care 1-2 28 39.29% (11/28) 29 72.41% (21/29) 3
Jin28 (2013) China RCT 102 57/45
N Mean 73.3±4.2 Regular skin care 1-3 49 9.4% (5/53) 53 44.9% (11/49) 2
29
Nie (2012) China RCT 85 60/25 Mean 67 Gauze care 1-2 42 0% (0/42) 43 20.93% (9/43) 2
Zhu30 (2014) China RCT 84 52/32 50-82 Gauze care 1-2 42 2.4% (1/42) 42 19.0% (8/42) 2
31 b
ot
Liu (2017) China RCT 120 70/55 Mean 73.5 Regular skin care N/Aa 60 5% (3/60) 60 16.67% (10/60) 2
Deng 32 (2016) China RCT 64 39/25 Mean 79 Gauze care 1-2 32 3.12% (1/32) 32 37.5% (12/32) 2
Jiang 33 (2015) China RCT 100 62/38 Mean 64.5±11.8
D Gauze care 1-3 50 6% (3/50) 50 28% (14/50) 2
34
Zhang (2012) China RCT 100 67/33 Mean 78.1 Gauze care 1-2 50 2% (1/50) 50 16% (8/50) 2
Deng 35 (2013) China RCT 64 39/25 Mean 11.8 months Regular skin care 1-2 32 9.4% (3/32) 32 34.4% (11/32) 2
up
Zhu36 (2012) China RCT 125 74/51 50-87 Regular skin care 1-2 68 4.41% (3/68) 57 17.54% (10/57) 2
b
Shi37 (2011) China RCT 62 43/19 Newborn Regular skin care N/A 31 0% (0/31) 31 77.42% (24/31) 2
Wu38 (2011) China RCT 107 68/39 Mean 63 Regular skin care 1-2 53 9.34% (5/53) 54 66.67% (36/54) 2
lic
39
Zhang (2017) China RCT 100 52/48 45-80 Gauze care 1-2 50 8% (4/50) 50 24% (12/50) 2
Lin40 (2017) China RCT 60 35/25 40-62 Regular skin care 1-3 30 20% (6/30) 30 90% (27/30) 2
Yang41 (2011) China RCT 80 61/19 53-82 Regular skin care 1-3 40 7.5% (3/40) 40 27.5% (11/40) 2
b
at
43
Xu (2013) China RCT 500 293/207 23-36 weeks Regular skin care N/A 250 0.4% (1/250) 250 1.2% (3/250) 2
Li44 (2018) China RCT 166 102/64 50-81 Gauze care 1-2 83
e
3.61% (3/83) 83 14.46% (12/83) 2
42
Peng (2017) China RCT 100 63/37 Mean 72 Regular skin care 1-3 50 6% (3/50) 50 20% (10/50) 2
a
The study did not report the gender of included population. bThe study did not report the pressure ulcer stage. M=male; F=female; RCT=randomized controlled trial; PU=pressure ulcer

33
Preventing facial pressure ulcers
figure 2. Forest plot of pressure ulcer outcomes in control and hydrocolloid
groups.
ot
N
figure 3. Sensitivity analysis by random effect model.
o
D
not materially change the result of the
meta-analysis, indicating the outcome of
the meta-analysis was robust (see Figure
3). The funnel plot showed asymmetry,
suggesting a publication bias in this me-
ta-analysis (see Figure 4).
Results of subgroup analysis. The
meta-analysis of pediatric patients
showed that in the hydrocolloid dressing
group, 4 patients (1.28%) developed PUs
versus 38 (12.14%) in the control group
(OR = 0.09; 95% CI: 0.01-0.81; P = .03).
23-34,36,38,42-44
In the 19 studies that included
adult and geriatrics patients, 63 patients
34
lic
up
D
(6.65%) developed PUs in the hydrocol-
loid dressing group versus 263 (27.80%)
in the control group (OR = 0.16; 95% CI:
0.12-0.22; P<.00001). Forest plot chart
analysis indicated no differences in OR
estimates were found across all age
groups (see Figure 5).
23,27,29,30,32-34,39,44
In the 9 studies
gauze was the control, meta-analysis
showed 27 patients (6.01%) in the hy-
drocolloid dressing group developed
PUs versus 108 (23.53%) in the control
group (OR = 0.17; 95% CI: 0.10-0.28; P
24-26,28,31,35-38,40-43
<.00001). In the 13 studies
in which regular skin care was the con-
trol, 40 patients (4.93%) developed PUs
in hydrocolloid dressing group versus
193 (24.13%) in the control group (OR
= 0.13; 95% CI: 0.09-0.19; P <.00001).
Forest plot chart analysis indicated no
differences in OR estimates were found
among different interventions in the
control group (see Figure 6).
DISCUSSION
23-44
This meta-analysis of 22 studies
e
demonstrated that a hydrocolloid dress-
ing was significantly more effective in
preventing facial PUs caused by NIV
at
than gauze or what was termed regular
skin care, decreasing the incidence of fa-
cial PUs caused by NIV (OR = 0.15; 95%
CI: 0.11–0.20; Z = 12.72; P <.00001). In a
45
prospective controlled trial, the inci-
dence of nasal injury using silicone gel
sheeting on the surface of the nostrils
was 4.3% in neonates versus 14.9% in pa-
tients who did not use silicone gel. In a
46
prospective study (N = 47) of patients
who needed NIV, the use of water to seal
the facial mask decreased the incidence
of facial PUs. These 2 studies reported
the use of different methods to prevent
facial PUs, but the outcome was similar
to the current research.
NIV usually involves a mask or sim-
ilar device to provide ventilation sup-
47
port ; correct mask placement is a key
factor in the successful use of NIV, as
17
noted in a quasi-experimental study
that showed that in normal clinical
practice, masks used in NIV are tight-
ly fitted to the face to prevent air leaks
and if fitted too tightly, PUs can devel-
op. This is especially true in areas where
the skin covers thin subcutaneous tis-
sue (chin, cheekbones, forehead, and
nasal bridge) and excessive pressure
11
predisposes to the development of PU.
48
A review of the literature has shown
patients with NIV need to wear masks
for a long time, and pressure-induced
in which ischemia at 35 mm Hg for a duration of
2 hours can inflict tissue damage and
48
necrosis. In the pediatric population,
particular risk factors include imma-
ture skin, and masks in less-than-opti-
mal size and fit for the facial anatomy of
19,49
each child.
February 2019  |  vol. 65, no. 2
Cai et al
figure 4. Funnel plot for publication bias.
ot
N
o
D
figure 5. Subgroup analysis of pressure ulcer outcomes in control and ventilation. Therefore, the hydrocolloid
hydrocolloid groups by age.
19
Riquelme et al constructed a sim-
ulated model of NIV using a total face
mask and explored preventive strategies
for facial PUs that involved the use of
suitable masks, fixed optimal pressure,
and unspecified periodic revision of the
www.woundmanageprevent.com
at
lic
up
D
11
skin. In a before-after study of a conve-
nience sample of patients with NIV (N =
200), full-face masks were considered a
reasonable alternative to traditional na-
sal-oral masks because their use result-
ed in significantly fewer PUs and more
comfort for patients in intensive care
units. Dressings can be used to elim-
inate the gap between the skin and the
mask to achieve a proper fit as well as
to redistribute the pressure. Moreover,
clinicians need training on the proper
application of the NIV mask, especially
17,50
correct mask placement and angle. A
51
prospective cohort study (N = 3233) has
suggested continuous monitoring is de-
sirable for facial PU prevention.
Hydrocolloid dressings are a viable
e
option for use in preventing PUs be-
cause they are occlusive, waterproof,
and impermeable to bacteria and other
52
contaminants. A meta-analysis con-
ducted to determine the effectiveness
of dressing material in the prevention
of PUs has shown the dressing to absorb
small to moderate amounts of moisture
to keep the skin intact. In an experi-
53
mental study, Ohura et al measured
the physical properties of dressings
with regard to shear force; results indi-
cated the coefficients of static friction
were 1.01 for hydropolymer, 0.72 for
hydrofoam, and 0.48 for hydrocolloid.
Therefore, a hydrocolloid dressing was
considered the most effective material
to address shear force in dry conditions.
17
The prospective study by Weng et al
of 90 patients with NIV that evaluated
the capacity of both hydrocolloid and
transparent polyurethane dressings to
prevent facial PUs found no significant
difference in skin deterioration between
the 2 groups, but PU incidence was 40%
in the hydrocolloid dressing group and
53.3% in polyurethane film group. In
their prospective study, Callaghan and
54
Trapp reported the hydrocolloid dress-
ing group had less skin deterioration
over time compared with the transpar-
ent polyurethane group in patients us-
ing nasal intermittent positive pressure
dressing is effective in preventing facial
PUs and protecting the skin.
LIMITATIONS
Several limitations are inherent to
meta-analyses. In this study, most pub-
lications had a Jadad score of 2, indicat-
ing the studies were of low quality and
biased. In addition, no English language
35
Preventing facial pressure ulcers
figure 6. Subgroup analysis of pressure ulcer outcomes by intervention in the
control group.
studies were found; the included articles
were all Chinese studies, which may con-
ot
tribute to bias and make it challenging
for non-Chinese researchers to confirm
current findings. Finally, the funnel plot
N
showed asymmetry, and publication bias
was found. The final conclusion was that
more high quality RCTs involving other
ethnicities are needed.
o
CONCLUSION
D
A meta-analysis of 22 RCTs showed
use of a hydrocolloid dressing effective-
ly decreased the incidence of facial PUs
in patients with NIV. Because the con-
clusions reached were mostly based on
low-quality RCTs, the findings need to
be further verified with more high qual-
ity RCTs. This research could help sup-
port the role of hydrocolloid dressings in
preventing facial PUs caused by NIV. n
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