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DERMATOLOGIC THERAPY
ISSN 1396-0296
ABSTRACT: Adequate wound bed preparation is essential for healing of leg ulcers, and consists of
controlling exudate and edema, decreasing the bacterial burden, promoting healthy granulation
tissue, and removing necrotic tissue. Currently, there is no classification system for wound bed preparation that has predictive value. Based on past work and the authors experience, we have now
developed and tested a new classification system that scores the following parameters: healing edges
(wound edge effect), presence of eschar, greatest wound depth/granulation tissue, amount of exudate
amount, edema, peri-wound dermatitis, peri-wound callus and or fibrosis, and a pink/red wound
bed. Each parameter receives a score from 0 (worst score) to 2 (best score), and all the parameter
scores are added for a total score. Each wound can have a maximum score of 16 (the best score
possible), to a minimum score of 0 (the worst score possible). We used this wound bed score (WBS)
system in a study of 177 patients with venous ulcers who had been prospectively treated with and
randomized to either conventional therapy (compression alone) or a living bilayered skin construct
(BSC). We evaluated serial photographs at baseline to determine whether the results would be predictive of complete wound closure and could validate the WBS. We found that wounds that ultimately
achieved full closure had a statistically significant higher WBS than those that did not heal
(p = 0.0012). This was also true when separating wounds by treatment modality: standard therapy
(p = 0.044) and treatment with a BSC (p = 0.011). When dividing the WBS in the following quartile
groups: scores 410, 1012, 1213, and 1316, the percentage of healed wounds correlated with the
WBS (p = 0.0008). For all wounds, a one unit increase in total WBS resulted on average in a 22.8%
increase in odds of healing (OR = 1.228). This WBS seems to have validity in predicting complete
wound closure in wounds treated with either standard therapy or advanced modalities, such as BSC.
If confirmed and widely adopted in this and other types of wounds, it could be a useful tool in both
the clinical and research setting.
KEYWORDS: bioengineered skin, prognosis, skin equivalents, wound, wound bed preparation, wound
healing
Introduction
Address correspondence and reprint requests to: Vincent
Falanga, MD, FACP, Professor of Dermatology and
Biochemistry, Department of Dermatology, Roger Williams
Medical Center, 50 Maude Street, Providence, RI 02908, or
email: vfalanga@bu.edu.
Dr Saap is presently with Affiliated Dermatology Cosmetic
Surgery Center, Dublin, OH.
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Falanga et al.
Wound bed
appearance score
A
B
C
D
Fibrinous tissue
Eschar
100
50100
< 50
Any amount
+
+
+
Wound exudate
score
Extent of
control
Exudate
amount
Dressing
requirement
Fully
None/minimal
2
3
Partially
Uncontrolled
Moderate amount
Very exudative wound
Adapted from Falanga V. Classifications for wound bed preparation and stimulation of chronic wounds. Wound Rep Reg 2000;
8 : 347352. Copyright V. Falanga, 2000.
384
Table 2. New Wound Bed Score ( WBS) and Its Individual Featuresa
Wound bed score
characteristics
Healing edges
Black eschar
Greatest wound
Depth/granulation
Tissue
Exudate amount
Edema
Peri-wound
Dermatitis
Peri-wound
Callus/fibrosis
Pink wound bed
None
> 25% of wound
surface area
Severely depressed or
raised when compared to
peri-wound skin
Severe
Severe
Severe
25 75%
0 25%
> 75%
None
Moderate
Flushed or
almost even
Moderate
Moderate
Moderate
Severe
Moderate
None
50 75%
None/mild
None/mild
None or
minimal
None or
minimal
> 75%
The total WBS adds each individual score for each characteristic to give a total score. The maximum possible score (best score) is
16. The minimum possible score (worst score) is 0.
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Falanga et al.
those taken at day 1 of the study, prior to assignment to either of the two treatment arms. The
control venous ulcer patients were treated with
standard therapy consisting of a nonadherent
primary dressing (Tegapore, registered trademark
3M Health Care, St Paul, MN), a secondary gauze
pressure bolster, a zinc paste bandage (Unna
boot), and a self-adherent elastic wrap (Coban,
3M Health Care); or with the BSC applied directly
to the wound, followed by the nonadherent
primary dressing, cotton gauze dressing folded
as a bolster, and the same elastic wrap. Patients
received up to five applications of BSC within the
first 21 days of the study. Re-application was
performed if less than 50% of the wound had reepithelialized (4). The original trial had a total of
146 patients treated with the BSC and 129 in the
control group. However, evaluable photographs
for the purpose of the present study were only
available from 83 control patients and 94 BSCtreated patients. This was either the result of
pictures not being taken at day 1 or patients leaving
the study prematurely so that healing or lack of
healing could not be assessed. Patients were
followed for a total of 12 months, and healing was
determined as 100% epithelialization with no
wound drainage by week 24.
Statistical analysis
The WBS was applied to each patient photograph,
as explained earlier. Healing percentages for each
score were determined by using the case report
forms provided for each patient. The independent
samples t-test was used to compare mean WBS
between healed and not healed wounds in all
patients, including control and BSC-treated
patients. This test was also used to compare mean
WBS between wounds that healed and those that
did not heal based on initial wound duration of
either less than 1 year to greater than 1 year prior
to enrollment into the protocol. The CochranArmitage trend test was used to evaluate the
association and trend between the WBS and complete wound closure. Logistic regression was used
to model total WBS as a predictor for healing status
(as a binary outcome) and to model total WBS
prior to treatment as a predictor for the duration
of wound. Finally, probability of healing was
modeled with a stepwise logistic regression model,
which includes each individual characteristic
one at a time, with an entry/removal threshold
of p = 0.10. This procedure allowed the present
authors to assess each individual characteristic
for its predictive power in the model.
386
Results
As stated earlier, photographs had not been submitted at day 1 for all study participants. Therefore, we were not able to analyze all the patients
initially enrolled in the study trial. These dropouts were not included in the data set for analysis
as there was no complete data for these subjects
to analyze. This also means that there was no way
to assess potential differential drop-out rates for
any of the subgroups used in the analyses. For
these reasons, we decided to omit the survival
analysis, although we examined association between
time-to-heal and bed score with other methods.
Therefore, photographs were evaluated for 177
patients at day 1 before any treatment was instituted. Of these 177 patients, 94 were treated with
BSC and 83 were treated with standard therapy
(control) as described in the methods section.
Using the independent samples t-test, we
found that the WBS at baseline was higher in the
subjects who healed (WBS = 11.83) compared to
those who did not heal by the 24-week mark
(WBS = 10.62; p = 0.0012). We also saw similar
results after separating the patients according to
treatment. Mean WBS score for patients treated
with BSC was significantly higher in patients who
healed (11.87) versus those patients who did not
heal (10.59) (p = 0.0113). In patients treated with
standard therapy, mean WBS score was also significantly higher in patients who healed (11.79)
versus those who did not heal (10.66) (p = 0.0439).
We then took the total WBS for all wounds (control
and treatment groups) and divided them into the
following four groups using roughly equiprobable
cut-off values or quartiles: 410, 1012, 1213, and
1316. We found a statistically significant trend
showing higher healing percentages for the WBS in
the higher quartiles (p = 0.0008 Cochran-Armitage
trend test) (FIG. 3).
Using logistic regression to model total WBS
(for both control and BSC-treated wounds) as a
predictor for healing status, we obtained the odds
ratio of 1.228 (p = 0.002). This can be interpreted as
meaning that one unit increase in total WBS
resulted on average in a 22.8% increase in the
odds of healing. For example, increasing the total
WBS from 10 to 13 leads to a 1.228 or 1.85-fold
increase in the odds of healing. The odds ratio for
wounds treated with BSC alone was 1.253
(p = 0.015) and for standard therapy alone was 1.202
(p = 0.010). Once again, this means that a one unit
increase in WBS leads to a 25.3% and a 20.2%
increase in odds of healing for wounds treated
with BSC and standard therapy, respectively.
FIG. 3. Total WBS and its correlation with healing for venous
ulcers. These data were for all venous ulcers (treated either
with standard therapy or a bioengineered skin substitute).
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Falanga et al.
Table 3. Modified WBS with the addition of wound duration prior to treatment
Wound bed score
characteristics
Healing edges
Black eschar
Greatest wound
Depth/granulation
Tissue
Exudate amount
Edema
Peri-wound
Dermatitis
Peri-wound
Callus/fibrosis
Pink wound bed
Wound duration
Prior to treatment
None
> 25% of wound
surface area
Severely depressed or
raised when compared to
peri-wound skin
Severe
Severe
Severe
25 75%
0 25%
> 75%
None
Moderate
Flushed or
almost even
Moderate
Moderate
Moderate
Severe
Moderate
None
Greater or equal to
1 year
50 75%
None/mild
None/mild
None or
minimal
None or
minimal
> 75%
Less than
1 year
The total WBS adds each individual score for each characteristic to give a total score.
The maximum possible score (best score) is 18.
The minimum possible score (worst score) is 0.
Table 4. Characteristics of components in the total WBS with the most predictive value for ultimate
wound healing, as assessed by a stepwise logistic regression model
Effect
Edges (2 versus 0)
Edges (1 versus 0)
P.callus/fibrosis (2 versus 0)
P.callus/fibrosis (1 versus 0)
Duration in years (= 1 versus > 1)
OR
p value
95% CI
1.783
0.744
9.335
1.998
4.579
2
1
2
1
=1
0.055
0.133
0.006
0.334
< 0.0001
(0.63, 5.08)
(0.26, 2.17)
(2.03, 42.83)
(0.79, 5.05)
(2.24, 9.35)
Discussion
Adequate wound bed preparation is essential for
healing of chronic wounds. Some of the principles
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Falanga et al.
are going to be required to use the WBS prospectively in cohorts of patients with different types of
chronic wounds. Ideally, one would like the WBS
to be applicable to wound bed preparation in
general, regardless of the etiology of the chronic
wound.
4.
5.
6.
Acknowledgments
This study was funded by NIH grants AR42936,
AR46557, DK067836 (VF), and the Wound Biotechnology Foundation.
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