UAB Observational Evaluation August 2015

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An observational evaluation
of a new foam adhesive dressing
Elizabeth Merlin-Manton, Michelle Greenwood
and Adele Linthwaite
This article is reprinted from the British Journal of Nursing (Tissue Viability Supplement), 2015, Vol 24, No 15
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An observational evaluation
of a new foam adhesive dressing
Elizabeth Merlin-Manton, Michelle Greenwood and Adele Linthwaite
Key words: Fibroblast proliferation TLC healing matrix
Silicone border Exudate management
N
ew wound care dressings are commonly
developed based on the ability to enhance wound
healing, while claiming unique features aimed at
improving the wound care experience for both
the patient and clinician. Wound dressings are known to have
various functions including the promotion of patient dignity,
enhancement of natural autolysis, moisture management, odour
control, improvement of the bacterial balance, and pain relief
for patient comfort. All of these elements have a role to play
to support the maintenance of the optimum wound healing
environment (Thomas, 1997). Some wound care dressings have
precise indications, while others are suitable for a much broader
range of wound types. However, all wound dressings can
Elizabeth Merlin-Manton, formerly Honorary Tissue Viability Nurse;
Michelle Greenwood, formerly Consultant Nurse, Tissue Viability; Adele
Linthwaite, Tissue Viability Nurse; all at Walsall Healthcare NHS Trust
Accepted for publication: June 2015
The technology
Many wound management dressings are available to clinician;
hence, this evaluation sought to ascertain the clinical
effectiveness of UrgoTul® Absorb Border and investigate its
claims of extensive advantages in relation to both participantand clinician-assessed outcomes (Bullough et al, 2014). The
dressing comprises a soft silicone border and a polyurethane
foam pad with an additional highly absorbent layer that is
covered with a non-adherent technology lipido-colloid (TLC)
healing matrix. The TLC healing matrix promotes a moist
wound healing environment and contains hydrocolloid and
lipophilic particles, which have been shown to promote the
proliferation of fibroblasts (McGrath et al, 2014). Additionally,
a lipido-colloid gel is created when these particles come into
contact with exudate, allowing maintenance of the optimum
moist wound healing environment (White et al, 2015).
A number of foam dressings contain a soft, silicone
layer across the entire surface to encourage the optimum
moist environment while supporting non-adherence of
the foam dressing to the wound bed (Bernard et al, 2007).
Silicone is hydrophobic (Meuleneire and Rücknagel, 2013);
therefore, these dressings will maintain a moist environment,
supporting wound healing. Silicone does not interact with
the wound in the same way as the TLC healing matrix
to enhance fibroblast proliferation (Bernard et al, 2005)
and, therefore, only has the ability to absorb fluid while
minimising the risk of adherence. Studies have shown that
the advantage of a foam with a TLC healing matrix is the
interaction within the wound, resulting in the stimulation of
fibroblasts during the proliferative phase of healing (Bernard
et al, 2005; Fays et al, 2005; Bernard et al, 2009).
Fibroblast proliferation has an essential role in assisting
the wound to progress along a normal and timely healing
trajectory (Schulz et al, 2005). This is achieved through the
fibroblasts that enable collagen and extracellular matrix (ECM)
synthesis, which is fundamental to the formation of new
granulation tissue. A reduction in the number of fibroblasts
present will naturally result in a much slower progression to
wound healing (Bernard et al, 2005).
UrgoTul Absorb Border is the only foam dressing that enables
direct contact between the TLC technology and the wound bed,
which is why the authors considered it necessary to evaluate
its advantages. UrgoTul Absorb Border has demonstrated
© 2015 MA Healthcare Ltd
Abstract
Following the work of Winter demonstrating the benefits of moist
wound healing, there has been a constant stream of wound care
products launched into the market to support this concept. This
article will describe the findings of an observational evaluation to
observe, document and analyse the clinical effectiveness of a new
foam adhesive dressing, UrgoTul® Absorb Border (Urgo Medical).
The main objective of the evaluation was to define the parameters to
allow data capture that would demonstrate the clinical effectiveness
of the dressing. Parameters studied and analysed included atraumatic
pain-free dressing changes; ease of dressing application; comfort and
conformability; exudate management; ability of the dressing to stay
in place; and peri-wound skin management. A total of 25 patients
with wounds suitable to be dressed using the evaluation product were
recruited following a full documented wound assessment by the tissue
viability nurse. Participants were selected across the organisation from
acute hospital wards and outpatient departments, care homes, wound
care clinics and the participants’ own homes. Digital photography
was used to demonstrate improvement or deterioration of the
wound bed and surrounding skin, and images were assessed by nonparticipating clinicians to confirm documented observations made
within the evaluation. The dressing was found to be clinically effective
in both chronic and acute wound types, and had an excellent level of
participant acceptance.
influence the way the wound progresses. The clinician must
have a clear understanding of the wound healing trajectory
and how the properties within the selected wound dressing can
enhance this process for the assessed wound (Thomas, 1997).
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PRODUCT EVALUATION
an ability to manage exudate (Bullough et al, 2014) and
enhance proliferation of fibroblasts by 45% (Bernard et al,
2005; Meuleneire and Rücknagel, 2013), while simultaneously
achieving peri-wound skin management, atraumatic removal
and pain-free dressing changes (Benbow and Iossen, 2004;
Smith et al, 2004; Urgo Medical, unpublished observations).
The study set out to investigate the tolerability and
acceptability of the dressing, and included the assessment of
a variety of wound types by their aetiology and with specific
patient-focused parameters. These parameters for observation
included comfort, healing rates, absorption, and the ability of
the dressing to remain in situ while enabling the participant
to continue with their normal, daily activities without the
need for dressing interference.
© 2015 MA Healthcare Ltd
Method
Before the initiation of the multi-site observational evaluation,
it was registered with the procurement department of the
trust for authorisation to undertake this work across Walsall
Healthcare NHS Trust. Clinical photographs were taken and
full informed patient consent was gained before definitive
recruitment. Participants were recruited across a number of
care settings within the integrated organisation including
care homes, wound clinics, patients’ own homes, outpatient
departments and acute hospital wards.
The consultant tissue viability nurse, in conjunction with
the honorary contract tissue viability nurse, developed the
bespoke evaluation data-collection tool to capture detailed
baseline information and parameters to be evaluated. This
tool was designed to ensure a consistent approach by
all involved, as participating clinicians ranged from tissue
viability nurses and wound care clinic nurse leads, to
community nurses, district nurses and care home nursing
staff. The intention was to recruit patients over a 6-month
period from the care settings identified. The data-collection
tool was initially piloted on five patients from across the
Walsall healthcare economy prior to full implementation.
Following this pilot period, no amendments were deemed
necessary as all participant parameters were included. The
tool design supported standardised data-capture and ease of
completion to allow for the range of clinicians who would be
involved in documenting their findings.
The inclusion criteria were:
Presence of epithelial and/or granulation tissue
<50% slough
<50% necrosis
Minimum wound surface area of 10 mm x 5 mm
Ability to give informed consent
No maximum wound surface area
Low-to-moderate exudate levels
Patients aged 18 years or older
All wounds were considered suitable for inclusion, regardless
of duration. Acute wounds were defined as less than 6 weeks
old and chronic wounds as over 6 weeks in duration.
The exclusion criteria included:
Any patient not able to give written and verbal consent
Presence of infection within the wound bed
A wound that required more active treatment, such as
desloughing or debriding
Table 1. Evaluation parameters
Wound
Patient
Clinician
Dressings
Duration
Patient comfort
during wear
Ease of application
Previous dressings
used
Aetiology
Patient comfort on
dressing removal
Conformability
Ability to stay in
place
Size
Allowance of
normality for daily
routines
Ease of atraumatic
removal
Ability to handle
exudate
Exudate levels
Patient discomfort
on dressing
removal
Condition of periwound skin
Peri-wound skin on
initiation
Table 2. Likert scale
Excellent
Very good
Good
Fair
Poor
Abdomen (n=1)
Lower limb (n=13)
Sacrum (n=3)
Breast (n=1)
Foot (n=2)
Hip (n=1)
Knee (n=1)
Ankle (n=1)
Figure 1. Wound locations
Pressure damage (n=6)
Venous leg ulcer (n=7)
Arterial leg ulcer (n=1)
Mixed aetiology leg
ulcer (n=4)
Traumatic wound (n=2)
Dehisced surgical
wound (n=2)
Palliative wound (n=1)
Figure 2. Wound aetiologies
Patients who were less than 18 years of age.
Irrespective of previous dressings used, any patients who met
the selection criteria were recruited into the evaluation. Before
use of the evaluation dressing, previous products used by the
participants were either thin hydrocolloid dressings or silicone
adhesive foam. As these patients’ wounds had not progressed
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PRODUCT EVALUATION
Figure 3. Peri-wound skin at baseline
Dressing rated as very
good or excellent
96
94
Percentage %
92
90
88
86
84
82
y
dr
r es
Co
Ea emo sing
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s
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on
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ou o
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sk riin
ilit
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or
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ab
ud
nf
tc
om
fo
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e
80
Figure 4. Study parameter outcomes
towards healing, it was considered acceptable to include them
in the product evaluation.
The evaluation parameters included patient details, relevant
past medical history, wound characteristics and previous
dressings used (Table 1). Dressing performance and patient
parameters were measured using a Likert scale ranging from
poor to excellent (Table 2). The data were then entered into
an Excel spreadsheet designed purposefully to support the
data entry, analysis and presentation of the findings.
The frequency of dressing changes ranged from one to
three times weekly, depending on the wound and exudate
level. The wound and the dressing were assessed against the
evaluation parameters during each dressing change. The
treatment protocol was for participants to continue with
their current wound management regime, with the only
adjustment being that UrgoTul Absorb Border replaced the
previous dressing in use.The participants remained within the
evaluation for a 6-week period unless healing was achieved
before to this time.
Results
A total of 25 patients were selected for inclusion into the
observational evaluation. The data for two patients were
not included owing to lost paperwork, leaving a total of 23
participants whose data are included in the findings. The mean
age was 82 years old with a female-male split of 57% (n=13)
and 43% (n=10), respectively. The wound duration ranged
from 3 days to greater than 2 years, with a mean chronic
wound age of 48 weeks. Chronic wounds accounted for 83%
(n=19) of the participants, while the remainder had acute
wounds (n=4). The area of the body affected by the wound
varied but included some difficult-to-dress areas, such as the
breast, hip and knee (Figure 1), with a number of wound
aetiologies (Figure 2). Wound size ranged from the minimum
wound size for inclusion (10 mm x 5 mm) to the largest, some
of which were circumferential on the lower limbs.
Of the 23 participants, only 3 (13%) were self-caring and able
to bathe or shower independently. However, when questioned
on dressing adherence, all stated the ability of the product to
remain in situ for three showers within a 7-day period.
Figure 3 shows the condition of the peri-wound skin
on initial assessment in the evaluation. At the end of the
evaluation, a total of 87% (n=20) of the participants showed
an improvement to this surrounding area.
The optimum moist wound healing environment relies
on effective management of excess exudate. Exudate levels
recorded varied from light/low levels to high, with the
majority (70%; n=16) being within the light-to-low category.
By the end of the evaluation, all participants had either
© 2015 MA Healthcare Ltd
Healthy (n=10)
Dry and flaky (n=5)
Inflamed (n=5)
Non-blanching
erythema (n=1)
Macerated (n=2)
The honorary contract tissue viability nurse delivered
training to all staff regarding application and removal
techniques for the evaluation product before commencement
of the evaluation. A standard evaluation pack was left with
each recruitment site and the completion monitored by the
lead author. The authors recognise the subjectivity of this
data but aimed to minimise this through guidance on how
to complete the evaluation form and ongoing monitoring.
Data were collected at each dressing change with a full
wound review documented. In addition to this, a digital
photograph was taken. To ascertain the level of patient
acceptability, a sequence of comfort-related questions were
verbally asked by the clinician making the assessment using
the Likert scale (Table 1).
The clinicians were asked to rate the assessment based on
their observation of dressing application, ability to stay in
place and handle exudate, conformability, ease of removal and
condition of the patient’s peri-wound edge. Patient comfort
on dressing removal was assessed using the visual analogue
pain scale (Collins et al, 1997).
The photographs were evaluated by the tissue viability
team. However, in order to limit the potential for bias, nonparticipant clinicians were asked for their opinions on the
wound status at baseline and on completion of the evaluation.
These clinicians were tissue viability team members who
were not involved in the evaluations. On completion of
the evaluation period, all data-collection tools, photographs
and supporting documentation were returned to the tissue
viability team for data entry.
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PRODUCT EVALUATION
Case Study 2
Case Study 1
Wound on presentation at the wound clinic
Wound on presentation at clinic—maceration is present
Dressing on removal after 7 days wear-time, demonstrating
vertical absorption capabilities
The wound at the end of the evaluation period
© 2015 MA Healthcare Ltd
After using UrgoTul Absorb Border for a 5-week period
none or light-to-low levels of exudate demonstrating an
improvement. Data analysis of the dressing’s ability to manage
exudate indicates that the clinicians have rated 96% (n=22)
of the evaluations as either ‘very good’ or ‘excellent’. The
remaining 4% were recorded as ‘good’.
All participants received a minimum of six evaluation
dressing changes with the exception of 17% (n=4) who
achieved full healing within a 5-week period.
The results (Figure 4) demonstrated a wide range of notable
outcomes. A total of 135 dressing changes were completed
across the 23 wounds, suggesting a mean of 6 dressing changes
per participant. Where the community nurse teams and
care home staff were completing the dressing changes, they
were responsible for ensuring the evaluation documentation
was complete. In 96% (n=22) of the wounds observed, the
clinicians rated the conformability of the dressing as ‘very good’
or ‘excellent’ with the remaining 4% (n=1) rated as ‘good’. At
no time was it documented that the dressing adhered to the
wound or caused any trauma, either while in situ or on removal.
As a result of non-concordance from one patient, the dressing
remained in place for 14 days and despite a recommended
average wear-time of up to 7 days, the wound improved.
Further results reported for the parameter, ‘patient comfort
during wear’ included 4% (n=1) rated as ‘good’, and 96%
(n=22) rated as ‘very good’ or excellent. For the parameter,
‘ability to remain in position’, 87% (n=20) were reported as
‘excellent’ or ‘very good’ by clinicians.
This included 30% (n=7) of the total wound dressings, which
used compression therapy in addition to the primary evaluation
dressing. On removal of the compression, the dressing remained
in situ with no evidence of slippage under the bandage and was
removed by the clinician with ease. One clinician documented
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PRODUCT EVALUATION
Case Study 3
Case Study 4
The wound measured 1 cm x 0.5 cm x 0.2 cm on initiation
Wound on presentation at the wound clinic
UrgoTul Absorb Border in position after 4 days wear-time
demonstrating conformability and ability to stay in place
Wound at first dressing change (day 7): there was a 56% wound
surface area reduction
The wound at 28 days
UrgoTul Absorb Border in situ
that she felt she had used an inappropriate dressing size for a
difficult-to-dress wound area and once this was amended, her
parameter rating for ‘ability to stay in place’ increased.
Four case studies representing the different wound types
and locations included in the evaluation are described.
Case Study 1
Complete healing at day 58
owing to the direct contact between the TLC healing matrix
and the wound bed and surrounding skin, with the rationale
to minimise the current pruritis, offer extra absorbency and
stimulate wound healing. The patient attended the wound
clinic on a weekly basis for dressing changes and despite
© 2015 MA Healthcare Ltd
A 54-year-old female patient presented to the wound clinic
with a traumatic wound to her left foot. On initiation, the
wound measured 1 cm x 1 cm with minimal depth and had
been present in excess of 9 months with no improvement
seen. Previous treatment included a foam adhesive dressing
with silicone in contact with the wound bed. The wound care
nurse chose to use the UrgoTul Absorb Border for this patient
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PRODUCT EVALUATION
showering a minimum of three times per week, the dressing
remained in situ. UrgoTul Absorb Border alleviated the pruritis
and improved the peri-wound skin, which has been prone to
irritation from previous wound dressings.
Case Study 2
An 84-year-old female patient presented to the wound clinic
with a circumferential venous leg ulcer to her left leg. The
wound had areas of maceration evident and had been present
in excess of 3 months with no improvement seen. Previous
treatment included a wound contact layer and absorbent pad
beneath a short stretch bandage. The tissue viability nurse
chose to use the dressing, with the rationale being to alleviate
maceration of the wound, offer extra absorbency, stimulate
wound healing and allow pain-free dressing changes. Use of a
short-stretch bandage was continued to promote venous return.
Case Study 3
An 85-year-old male patient was recruited for the study as his
chronic abdominal wound was not progressing as expected
with a silicone foam dressing. Exudate levels were not being
efficiently managed with this dressing. Therefore, enhanced
fibroblast proliferation and absorbency were the specific
considerations for this patient. The wound measured 4.5 cm
x 6c m on commencement with UrgoTul Absorb Border and,
within 7 days, the exudate was effectively managed and the
wound measurements reduced to 6 cm x 2 cm (at the widest
point), representing a 56% reduction in wound surface area.
Before his care was transferred out of the area, the final wound
measurements were 5 cm x 1.9 cm at day 28, equalling a total
surface area reduction of 64% within 4 weeks.
Case Study 4
A doubly incontinent, 80-year-old female patient with a
pressure ulcer on her sacral area was initiated by a member of
the tissue viability team and followed up by the district nursing
team, who had previously prescribed a silicone foam dressing
which caused distress to the patient on removal. Although
pressure redistribution was a contributing factor, this had been
continually in place during the previous dressing regime where
there had been no healing progression.
© 2015 MA Healthcare Ltd
Discussion
The ability to maintain normality and patient acceptability are
key criteria for any clinician carrying out an evaluation of a
new product. This study recruited 23 participants to evaluate
UrgoTul Absorb Border within an integrated healthcare
organisation. The clinical effectiveness has been demonstrated
by the encouraging results; however, the authors acknowledge
that the sample size was small and further clinical outcomes
may be explored with more specific data capture, particularly
in relation to wound surface area and levels of exudate. The
bespoke evaluation tool could also be enhanced to capture
more in-depth patient parameters as this would enable a more
comprehensive understanding with comparative data capture.
To depict a much broader range of wounds by aetiology
with larger participant numbers would be more accurately
representative of the local demographics within the integrated
healthcare organisation’s population.
Incorporating the TLC healing matrix layer into the
adhesive foam dressing (UrgoTul Absorb Border) that interacts
with the wound bed has the benefit of enhancing fibroblast
proliferation. Foam dressings containing silicone that have
direct contact with the wound bed do not offer this advantage.
The measurement of the participants’ experience of pain
can be very subjective; therefore, use of a visual pain scale
attempts to capture levels of pain via a more consistent means.
With the capacity to remain in place, manage moisture
and avert further trauma to the patient and wound, UrgoTul
Absorb Border has been shown to meet patient and
clinician expectations, and has the potential to achieve
economic benefits by reducing dressing-change frequency
and accelerating healing times.
Conclusion
This observational evaluation found UrgoTul Absorb Border
to be a versatile dressing as it demonstrated effectiveness
across a selection of both acute and chronic wounds when
used as a primary dressing. It demonstrated the ability to
manage wound exudate levels and improve surrounding skin.
Throughout the evaluation period, all wounds showed an
improvement and progression to healing. The atraumatic,
pain-free dressing removal was reported by participants who
also found the dressing to be comfortable and reported that it
allowed them the freedom to carry out their normal activities
of daily living, such as having a shower.
Both clinicians and participants involved in the study
confirm that none of the dressings used adhered to the
wound bed, making this dressing an suitable choice for a wide
BJN
range of both acute and chronic wounds.
Conflict of interest: this study was made possible by an educational
grant supported by Urgo Medical Ltd. UrgoTul Absorb Border is a
registered trademark of Urgo Medical Ltd. Elizabeth Merlin-Manton
was an Urgo Medical employee when this evaluation was conducted
and written. Michelle Greenwood became an Urgo Medical employee
after this evaluation was completed
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range with technology lipido-colloid (TLC) [Poster]. Wounds UK, Harrogate. http://
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impact on clinical practice. J Wound Care 14(6): 273–6
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Urgo Limited, Sullington Road, Shepshed, Loughborough, LE12 9JG
Tel: 01509 502051 Fax: 01509 650898 Email: Woundcare@uk.urgo.com Web: www.urgo.co.uk
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