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Article history:
Received 18 January 2014
Received in revised form 10 August 2014
Accepted 13 August 2014
Keywords:
Wound irrigation
Wound cleansing
Pressurised irrigation
Swabbing
Cleansing techniques
Healing time
Randomised controlled trial
A B S T R A C
T
89
did swabbing group. Wound infection was reported in 4 (3.3%) patients in pressurised
irrigation group and in 7 (5.2%) patients in swabbing group (p = 0.44). Cost-effectiveness
analysis indicated that pressurised irrigation in comparison with swabbing saved per
patient HK$ 110 (95% CI:
33 to 308) and was a cost-effective cleansing method at no
extra direct medical cost with a probability of 90%.
Conclusions: This is the rst randomised controlled trial to compare the pressurised
irrigation and swabbing. Pressurised irrigation is more cost-effective than swabbing in
shortening time that wound heals by secondary intention with better patient tolerance.
Use of pressurised irrigation for wound cleansing is supported by this trial.
2014 Elsevier Ltd. All rights reserved.
2.3. Intervention
For patients allocated to the study group, wounds
were cleansed with pressurised irrigation technique
using a pressurised irrigation device (Fig. 1) which was
modied by connecting an instrument DeVilbiss Syringe,
1
to Gomcos
Vacuum/Pressure Pump Model 309,
gener- ating a steady irrigation stream at a consistent
range of impact pressure from 4 to 13 psi. The Syringe is
a small exible tube with opening in forward end
furnished with a bottle to hold liquid, which permits
deep yet painless lavage.
Pressurised irrigation group received the standardised
usual care the same as those in the control group that
had wounds cleansed with swabbing technique using
forceps and cotton wool (in sterile dressing pack). The
standar- dised usual care included cleansing wound
with normal saline solution at room temperature; used
saline to be dated and used within 24 h after opening;
selecting wound dressing according to the protocol of
wound management in GOPC; all dressings being kept
intact until next visit; and amount of saline used and
frequency of dressing change depending on the amount
of exudates.
The wound care practice in GOPCs was guided by the
protocol consisting of three basic elements in wound
management: cleansing techniques, cleansing solutions
and dressings. Since the cleansing techniques were the key
aspect this study was testing, only the standard care about
cleansing solution and dressing used were addressed.
Normal saline is isotonic that is the most commonly and
safely used to cleanse wound. The principle of dressings
selection is guided by moist wound theory in keeping wound
moist and controlling exudate, as well as availability of the
dressings that a variety types of dressing materials, e.g.
alginates, hydrober, hydrocolloid, foam are usually available in the GOPCs.
All
wounds were cleansed following the
allocated method until the wounds were completely
healed or for
6 weeks if the wounds had not yet healed.
2.4. Data collection
Data collection and wound assessment took place for
all subjects at enrollment and upon healing of the wound
or at the end of 6-week period if the wounds had not yet
healed. Wounds that had not healed at the end of the 6week period were reassessed and data relating to the
wound characteristics were recorded. The operators who
undertook dressing change were responsible for the
ongoing assessment of the wound during cleansing and
recording the information on the volume of solution and
amount of cleansing materials used, frequency of
dressing changes and the type of dressing applied at
each visit.
Data for checking baseline differences and data related
to wound healing problems were abstracted from the
medical records. The collected data included age, sex,
body weight & height, history of smoking, medical
history, concomitant medication, current treatment and
abbrevi- ated mental test (AMT). Bates-Jensen Wound
Assessment Tool (BWAT) (Bates-Jensen, 2000, 2001)
comprising
108 accrued in
GOPC A
8 accrued in
GOPC B
41 accrued in
GOPC C
99 accrued in
GOPC C
Randomization
Study Group
Cleansing by PI
Control Group
Cleansing by swabbing
122 patients
134 patients
16 dropped out
23 dropped out
Study Group
106 patients completed the
treatments in accordance
to the protocol
Control Group
111 patients completed the
treatments in accordance to
the protocol
13 assessment scored items (size, depth, edges, undermining or pockets, necrotic tissue type, necrotic tissue
amount, exudate type, exudate amount, surrounding skin
colour, peripheral tissue oedema, peripheral tissue induration, granulation tissue, and epithelialisation) was
adopted to capture the baseline wound features, and the
lower scores indicates a healthier wound.
2.5. Clinical outcome measures
The primary outcome was time-to-wound
healing dened as number of days from recruitment to
complete
fZ 1 a=2
p
2 p 1
Z 1 b
p1 1 p1 p2 1
d
p2 g
N
required for cleansing were recorded when they
attended the appointment for wound assessment in
other hospitals.
wherep p1 p2 =2
Considering about 25% of patients loss to follow-up or
withdrawn from this trial, the sample size was inated
to
122 patients in each arm.
2.8. Statistical analysis
All the main primary and secondary outcome
measures, except patient satisfaction and health-related
quality of life, were analysed on the basis of intentionto-treat (ITT) principle. In
view of the gradually
improving nature of these outcome measures, missing
outcome data, except time-to-wound healing, were
imputed using last observa- tion carried forward
approach, where more conservative efcacy results
would generally be
obtained. In
the survival
analysis of time-to-wound healing, the
dropped-out cases owing to adverse events were considered as having unfavourable outcome (incomplete wound
healing) throughout the study period (6 weeks) if
they have not reached the
endpoint before the
occurrence of adverse events. All other dropped-out (lost
to follow-up) patients were considered as censored cases
in the survival analysis.
Time-to-wound healing was estimated by Kaplan
Meier method and compared between pressurised irrigation and swabbing using log rank test. Furthermore,
Cox proportional hazards model was used to estimate
the hazard ratios of the irrigation group versus
swabbing group on time to wound healing with
and without adjustment for covariates, including initial
wound size, receiving antimicrobial treatment at the
baseline and leg ulcer wound. These covariates are
supposed to affect the progress of
wound healing.
Proportion of wounds completely healed and infection
rate during follow-up as well as patient perceived
wound symptoms at study completion were compared
between the two arms using Pearson chi-square test or
Fishers exact test, as appropri- ate. Reduction of wound
area and percentage of reduction were both assessed
using MannWhitney test. Patient satisfaction and
health-related quality of life scores were compared
between
the two arms in
the per-protocol
population using MannWhitney test and independent
t-test respectively.
Since it is difcult to make justiable imputations to
the dropped-out cases, particularly, for cost data,
cost- effectiveness analysis of wound healing with
pressurised
Table 1
Baseline characteristics of the study subjects by randomisation group.
Cleansing by
swabbing
group (n = 134)
Age (years)
Gender
Male
Female
Education level
Primary or below
Secondary
Tertiary or above
Employment
Employed full-time
Retired
Other
2 y
Body mass index (kg/m )
Know chronic diseases
No
Yes
Smoking status
Non-smoker
Ex-smoker
Current smoker
c
Initial wound size (cm2)
Wound duration from onset
c
to study inclusion (days)
Overall wound status scorey
Wound types
Trauma wound
Burns/scalds
Dehisced surgical wound
Leg ulcer
Dog bite
Other
Wound anatomical region
Upper extremity
Lower extremity
Trunk
47.1
17.1
Cleansing
by irrigation
group (n = 122)
47.9
18.2
99 (73.9%)
35 (26.1%)
76 (62.3%)
46 (37.7%)
50 (37.3%)
70 (52.2%)
14 (10.5%)
48 (39.3%)
64 (52.5%)
10 (8.2%)
58 (43.3%)
36 (26.9%)
40 (29.8%)
23.8
4.2
58 (47.5%)
26 (21.3%)
38 (31.2%)
23.7 3.7
91 (67.9%)
43 (32.1%)
89 (73.6%)
32 (26.4%)
80 (65.0%)
22 (17.9%)
21 (17.1%)
69 (61.6%)
19 (17.0%)
24 (21.4%)
2.0 (0.89.5)
1.7 (0.66
6 (314)
5 (39)
28.1
36
25
21
10
6
36
3.8
(26.9%)
(18.7%)
(15.7%)
(7.5%)
(4.5%)
(26.9%)
52 (38.8%)
61 (45.5%)
16 (11.9%)
27.4
41
20
23
2
4
32
.6)
3.6
(33.6%)
(16.4%)
(18.9%)
(1.6%)
(3.3%)
(26.2%)
54 (44.3%)
57 (46.7%)
8 (6.6%)
Head/neck
5 (3.7%)
3 (2.5%)
Delayed healing due to bacteria
No
133 (99.3%)
122 (100.0)%
Yes
1 (0.7%)
0
Wound with risk of infection
No
132 (98.5%)
120 (98.4%)
Yes
2 (1.5%)
2 (1.6%)
Discolouration of granulation tissue
No
133 (99.3%)
122 (100.0%)
Yes
1 (0.7%)
0
Foul odour
No
134 (100.0%)
122 (100.0%)
Yes
0
0
Infection in wound receiving antimicrobial treatment
No
Yes
that all
97 (72.4%)
37 (27.6%)
98 (80.3%)
24 (19.7%)
Data marked with y are presented as mean standard deviation and with
c as median (inter-quartile range), all others are presented as frequencies
(%).
Table 2
Adverse events during the study period.
Cleansing by swabbing
group (n = 134)
Changed to antiseptic solution for cleansing after consultation with podiatrist
or wound specialist nurse
Wound complicated by tunnelling requiring admission and expert consultation
Wound changed to cleansing by irrigation after other clinicians review
Changed to surgical intervention and incision and drainage of wound
after consulting General Practitioner or physician
Total
Cleansing by irrigation
group (n = 122)
2 (1.5%)
1 (0.8%)
2 (1.5%)
2 (1.5%)
2 (1.5%)
0
0
0
8 (6.0%)
1 (0.8%)
Fig. 2. Proportion of patients with their wound healed across time in ITT population.
Table 3a
Wound healing outcomes in ITT population.
p value
78.4%
12.0 (10.213.8)
1.4 (0.36.9)
100.0 (100.0100.0)
5.2%
82.0%
9.0 (7.410.6)
1.3 (0.36.3)
100.0 (100.0100.0)
3.3%
0.470
b
0.007
c
0.701
c
0.225
a
0.443
Variables marked with c are presented as median (inter-quartile range), all others unless specied are presented as percentage.
a
Pearson chi-square test.
b
Log rank test.
c
MannWhitney test.
d
Estimated median time for completely wound healing and its 95% condence interval by KaplanMeier method.
Table 3b
Hazard ratios of the irrigation group versus swabbing group on time-towound healing.
Time-to-wound healing
Hazard ratio (95% CI)
1
1.44 (1.091.89)
0.010
1
1.43 (1.091.89)
0.011
0.95 (0.871.03)
0.188
Unadjusted model
Group
Swabbing (ref)
Irrigation
Adjusted model 1
Group
Swabbing (ref)
Irrigation
0.034
0.183
0.005
1
1.29 (0.971.70)
0.077
0.95 (0.871.03)
0.199
0.065
0.027
Table 4
Patient perceived wound symptoms at study completion in ITT population.
Cleansing by swabbing group (n = 134)
Wound symptom
Pain over wound
No/mild
Moderate/severe/very severe
Pain during wound cleansing
No/mild
Moderate/severe/very severe
Fluid leaking from wound cleansing
No/mild
Moderate/severe/very severe
Wound bleeding
No/mild
Moderate/severe/very severe
Wound smell
No/mild
Moderate/severe/very severe
Itchiness over wound or surrounding skin
No/mild
Moderate/severe/very severe
p value
80.6%
19.4%
81.1%
18.9%
0.911
84.2%
15.8%
93.4%
6.6%
0.020a
85.1%
14.9%
86.1%
13.9%
0.822a
96.3%
3.7%
97.5%
2.5%
0.725b
99.3%
0.7%
99.2%
0.8%
0.999b
79.9%
20.1%
73.8%
26.2%
0.249a
78.7%
21.3%
0.400
95.1%
4.9%
0.201a
95.1%
4.9%
0.868a
97.5%
2.5%
0.671
99.2%
0.8%
0.477b
91.8%
8.2%
0.652a
Table 5
Patient satisfaction and health-related quality of life scores (SF-12) at study completion in per-protocol population.
Cleansing by swabbing
group (n = 111)
Patient satisfaction
Overall patient satisfaction with wound cleansing method
Patient satisfaction with comfort after wound cleansing
Overall patient satisfaction with wound cleansing method
SF-12 subscale scores
Physical functioning
Role physical
Bodily pain
General health
Vitality
Social functioning
Role emotional
Mental health
5 (56)
5 (56)
5 (55)
67.3
22.1
57.2
50.0
70.3
74.5
64.9
72.8
25.2
40.8
30.4
28.0
28.0
34.0
40.8
25.1
Cleansing by irrigation
group (n = 106)
6 (56)
6 (56)
6 (56)
65.1
23.6
59.2
47.8
69.4
71.9
62.7
71.9
28.6
42.1
28.3
26.9
28.6
36.3
42.6
23.7
p value
0.161
a
0.002
a
<0.001
b
0.539
b
0.788
b
0.619
b
0.553
b
0.828
b
0.584
b
0.707
b
0.785
All the patient satisfaction items were rated by 6-point Likert scale (from 1 = very dissatisfactory to 6 = very satisfactory) and presented as
median
(interquartile range).
The SF-12 subscale scores are presented as mean standard deviation.
a
MannWhitney test.
b
Independent samples t-test.
Table 6
Cost-effectiveness of time to complete wound healing with pressurised irrigation method compared with swabbing method per-protocol population.
Cleansing by
swabbing group
(n = 111)
Cost
Cost
Cost
Cost
for
for
for
for
Cleansing by
irrigation group
(n = 106)
27.2
0.30
0.22
0.99
28.9
1.17
1.00
1.16
21.8
0.53
0.00
1.10
24.7
0.94
0.04
1.09
28.7
30.6
23.4
25.6
126.2
153.0
59.4
172.1
716.8
764.7
73.7
213.7
37.4
53.5
57.5
166.7
150.8
158.1
60.1
174.4
353.8
882.0
243.7
283.2
14.5 (1.1)
11.4 (1.0)
Mean difference
(95% CI)
110.1 (
32.8 to 308.3)
3.1 (0.35.9)
Mean (standard error) time to complete wound healing was estimated by the approach of Efron (1967).
Fig. 3. Cost-effectiveness plane of time to complete wound healing with pressurised irrigation method compared with swabbing method in perprotocol population.
Fig. 4. Cost-effectiveness acceptability curve for comparison between pressurised irrigation method and swabbing method in per-protocol population.
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