in control cambridge ltd - crawford healthcare · 2016. 12. 15. · rm s s n n n ak1 s n n n n ak2...
TRANSCRIPT
-
In Control Cambridge Ltd
1
A Study to evaluate antibacterial dressing, KerraContact Ag, in the
management of venous leg ulcers
Aim
The main aim of this study was to evaluate the ability of KerraContact Ag dressing to
reduce the clinical signs of infection in venous leg ulcers. Also recorded were
wound area changes over time which is an indicator of healing rate. The ease of use
of the dressing was also noted.
Introduction
Venous leg ulcer prevalence rates fall into the range 1.2 – 3.2 per 1000 people (1).
This means that at any one time in the UK there are 70,000 – 190,000 individuals
with a venous leg ulcer. Most venous leg ulcers will heal within 2 to 3 months if
treated by trained healthcare professionals using the correct compression therapy.
One of the main factors affecting the repair process is the presence of infection.
These chronic wounds provide the perfect medium for bacterial growth. The two
main treatments for wound infections are antibiotics which are systemic and also
topical treatments for the wound surface. In addition to this various secondary
dressings/bandages are needed to absorb the excess exudate. All of these things
add to the cost of treatment of venous leg ulcers.
This study aims to demonstrate that the silver dressing KerraContact Ag (Crawford
Healthcare) has a role in reducing the signs and symptoms of infection in venous leg
ulcers.
Method
A clinical evaluation was undertaken on 15 patients, 7 male and 8 females. The
mean age was 73yrs and there was a total of 17 wounds within this group that were
monitored over a period of 4 weeks. All patients had adequate perfusion
demonstrated by an ABPI > 0.7 and were able to ambulate in their home
environment or clinic with or without mobility aids. All wounds included in this study
had a surface area of between 1 – 20cm2.
-
In Control Cambridge Ltd
2
Clinical diagnosis of infection or suspicion of infection was judged by the presence of at least 2 of the following criteria:
Increased exudation
Purulence
Odour
Pain caused by wound
Friable dull granulation tissue
Erythema >1-2cm from wound margin
Following informed consent, the wounds were assessed and photographed once per
week and all relevant data recorded. The wound was photographed together with
patient identifier and ruler to assess changes in wound dimensions over time.
KerraContact Ag was applied as per manufacturer’s instructions.
Data was collected assessing the following:
Wound size/area
Level and type of wound exudate
Level of odour
Type of pain and pain level on application, wearing and removal of dressing
Integrity of periwound skin
Appearance of dressing on removal
Wear time of dressing
Results
The clinical staff involved in this study were impressed with the dressing KerraContact Ag and felt it was very effective in dealing with the wound infections. They did, however, make a comment about the rigid nature of the dressing which they said made it more difficult to apply than other dressings they had used. They said that they found it easier to apply if they screwed the dressing up in their hand a few times prior to applying it to the wound. This appeared to soften the dressing up and allow it to mould to the wound surface more effectively. Apart from that one point they were very satisfied with the dressing.
-
In Control Cambridge Ltd
3
Results
Treatment for previous 12 weeks
Table 1 shows the treatment the wounds were receiving prior to starting this study.
Table 1.
-
In Control Cambridge Ltd
4
Wound Size
The data in table 2 shows the mean wound area as a percentage of initial wound
area at time 0. This data is expressed graphically in figure 1.
Table 2. Wound area assessment
Mean % +/-SEM
Time 0 100 0
1 week 87.05 3.63
2 weeks 77.05 5.53
3 weeks 62.76 7.21
4 weeks 48.4 8.14
Figure 1. Graph showing change in wound area over time
The data shows that the wounds decreased in size over the 4 week treatment period
to a mean of 48.4% of the initial wound area which indicates that the wounds are
healing.
-
In Control Cambridge Ltd
5
Level and Type of Wound Exudate
The data in Table 3 shows the exudate level and also the type of exudate at each
weekly assessment.
Table 3.
Exudate Level / Exudate Type
Patient Time 0 1 week 2 week 3 week 4 week
FF M / P M / P M / P L / S L / S
HP M / HM M / HM L / S L / S L / S
JM M / P H / P M / P L / S L / S
JM2 M / P M / P M / S L / S L / S
KS M / P M / P L / S L / S L / S
MH M / P M / P M / S M / S L / S
RM M / P M / P L / S L / S L / S
AK1 M / P M / S M / S M / S M / S
AK2 M / P M / S M / S M / S M / S
AS H / P H / P M / S M / S M / S
DM L / P L / P L / HM L / HM L / S
EE M / P M / P M / P M / S L / S
ES H / P M / P M / P M / S M/ S
GM1 H / P H / P M / P M / P M / P
GM2 H / P M / P M / P M / P M / P
PR H / P H / P H / P H / P H / P
SD M / P M / P M / P M / S M / S
Key:
Exudate Level is also expressed in pie chart format in figure 2.
Exudate Level L = Low
M = Moderate
H = High
Exudate Type S = Serous
HM = Haemoserous
P = Purulent
-
In Control Cambridge Ltd
6
Figure 2a. Pie Chart showing the exudate level at time 0
Figure 2b. Pie Chart showing the exudate level after 4 weeks
The data shows that there has been a large change in exudate levels over the 4
week treatment period. At time 0 only 6% of the wounds were classed as low
exudating whereas the remaining 94% were classed as moderate to high exudating.
After 4 weeks of treatment only 6% of wounds were classed as high exudating
whereas 53% of the wounds were classed as low exudating.
-
In Control Cambridge Ltd
7
Figure 3 below shows the change in exudate type between time 0 and 4 weeks.
Figure 3a Exudate type at time 0
Figure 3b Exudate type after 4 weeks
The data shows that there is a large movement away from purulent exudate which
dominated the wounds at time 0 to serous exudate which dominates the wounds
after 4 weeks. This indicates that the infected wound percentage has demonstrated
a large decrease.
-
In Control Cambridge Ltd
8
Level of Odour
The data in Table 4 shows the level of odour detected at the assessment time point
dressing change.
Table 4.
Odour
Patient Time 0 1 week 2 week 3 week 4 week
FF S S N N N
HP N N N N N
JM S S S N N
JM2 S S N N N
KS S S N N N
MH S N N N N
RM S S N N N
AK1 S N N N N
AK2 S S N N N
AS S S N N N
DM S S N N N
EE S S N N N
ES S S S N N
GM1 M S S S S
GM2 M S S S S
PR M S S S S
SD S N N N N
Key:
Odour Level is also expressed in pie chart format in figure 4.
Odour N = None
S = Some
M = Significantly Malodorous
-
In Control Cambridge Ltd
9
Figure 4a. Pie Chart showing the odour level at time 0
Figure 4b. Pie Chart showing the exudate level after 4 weeks
Figure 4 shows that odour levels have dramatically reduced over the 4 week
treatment period. At time 0 94% of the wounds were odorous, 18% significantly so.
After 4 weeks treatment 82% of wounds were assessed as being not odorous and
the remaining 18% were odorous but none significantly so. This indicates a
reduction in infection.
-
In Control Cambridge Ltd
10
Pain
Table 5a shows the type of pain that was present throughout the treatment period.
Table 5a
Pain
Patient Time 0 1 week 2 week 3 week 4 week
FF 4 6 None None None
HP 2 + 5 2 + 5 3 + 5 None None
JM 1 + 2 2 1 + 5 1 + 5 1 + 5
JM2 None None None None None
KS 2 + 6 2 + 6 2 + 5 2 + 5 2 + 5
MH None None None None None
RM None None None None None
AK1 1 1 1 None None
AK2 1 1 1 None None
AS 1 + 2 5 1 + 5 1 + 5 5
DM 1 1 None None None
EE 5 5 5 5 None
ES 3 + 5 None None None None
GM1 1 + 2 + 4 1 + 2 + 6 1 + 2 + 6 1 + 2 + 6 1 + 2 + 6
GM2 1 + 2 + 4 1 + 2 + 6 1 + 2 + 6 1 + 2 + 6 1
PR 1 + 4 1 + 5 3 + 5 3 + 5 3 + 5
SD 3 + 5 3 + 5 3 + 5 3 + 5 3 + 5
Key:
Pain Type 1 = Burning
2 = Stabbing
3 = Aching
4 = Continuous
5 = Intermittent
6 = Itching
-
In Control Cambridge Ltd
11
Table 5b shows the pain level of that was experienced by each patient at 3 time
periods:
1 - Application of the dressing
2 - Wearing of the dressing
3 - Removal of the dressing.
Pain level was judged on a scale 1-10 with 1 being no pain and 10 being worst pain.
Table 5b.
Pain
Patient week 1 week 2 week 3 week 4
FF 1+4+1 1+1+1 1+2+1 1+2+1
HP 1+3+1 1+2+1 1+1+1 1+1+1
JM 1+1+1 1+5+1 1+5+1 1+3+1
JM2 1+1+1 1+5+1 1+1+1 1+1+1
KS 1+6+1 1+2+1 1+3+1 1+3+1
MH 1+1+1 1+1+1 1+1+1 1+1+1
RM 1+1+1 1+1+1 1+1+1 1+1+1
AK1 1+4+4 4+4+4 1+1+1 1+1+1
AK2 3+3+5 2+2+2 1+1+1 1+1+1
AS 4+4+4 2+4+5 1+2+2 2+1+1
DM 2+2+2 1+1+1 1+1+1 1+1+1
EE 4+4+4 4+4+3 5+5+5 1+1+1
ES 1+1+1 1+1+1 1+1+1 1+1+1
GM1 7+7+7 7+7+7 7+7+7 7+7+7
GM2 7+7+7 7+7+7 6+6+6 5+5+5
PR 1+4+2 1+4+2 1+4+2 1+2+1
SD 1+3+3 1+3+3 1+2+2 1+2+2
In the above table there are 3 numbers for each period:
First number = pain score on application of dressing
Second number = pain score on wearing the dressing
Third number = pain score on removal of the dressing
The data from table 5b is expressed graphically in figure 5.
-
In Control Cambridge Ltd
12
Figure 5. Bar Chart showing pain levels over 4 week treatment period.
Figure 5 shows that over the 4 week treatment period pain reduction was seen at
each of the 3 assessment points. Pain decrease is an indication that infection is
decreasing (2).
-
In Control Cambridge Ltd
13
Integrity of Periwound Skin
One of the clinical challenges of colonised or infected chronic wounds is protecting
the surrounding skin from the effects of moisture. The chronic wound will produce
increased amounts of wound fluid. If not absorbed or controlled by reducing the bio-
burden will lead to maceration and wound deterioration. Several parameters were
rated including maceration, oedema, and erythema at each assessment point. The
results are shown in table 6.
Table 6.
Periwound Skin
Patient Time 0 1 week 2 week 3 week 4 week
FF 6 6 4 4 4
HP 3 7 (callus) 1 1 1
JM 3 1 1 1 1
JM2 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema)
KS 7(Fragile) 7(Fragile) 1 1 1
MH 1 1 1 1 1
RM 1 1 1 1 1
AK1 6 6 1 1 1
AK2 5 1 1 1 1
AS 5 5 + 6 4 4 4
DM 1 1 1 1 1
EE 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema)
ES 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema)
GM1 4 + 6 4 + 6 1 1 1
GM2 5 + 6 4 1 3 1
PR 3 + 5 3 1 5 1
SD 5 1 1 1 1
Key:
Periwound skin condition 1 = Healthy
2 = Breaking down
3 = Macerated
4 = Erythema 1 – 2cm
5 = Erythema < 1 – 2cm
6 = Oedematous
7 = Other (Specify)
-
In Control Cambridge Ltd
14
The results from table 6 are shown in figure 6 which compares the periwound skin at
time 0 to that at the week 4 time point.
Figure 6a. Bar chart showing the condition of the periwound skin at time 0
Figure 6b. Bar chart showing the condition of the periwound skin after 4 weeks
The results demonstrate an improvement in the periwound skin of the patients with
most showing a healthy profile.
-
In Control Cambridge Ltd
15
Appearance of Dressing on Removal
The appearance of the dressing on removal was rated by the clinician. The rating
was based on judging the dressing on the following 4 factors:
Was the dressing - as applied, partially adhered, not insitu, desiccated
The results are shown in table 7.
Table 7
Appearance of Product
Patient 1 week 2 week 3 week 4 week
FF 1 1 1 2
HP 1 1 1 1
JM 2 1 1 1
JM2 1 1 1 1
KS 1 2 1 1
MH 1 1 1 1
RM 1 1 1 1
AK1 1 1 1 1
AK2 1 1 1 1
AS 1 1 2 1
DM 1 1 1 1
EE 1 1 1 1
ES 1 1 1 1
GM1 1 1 1 1
GM2 1 1 1 1
PR 1 1 2 2
SD 2 1 1 2
Key:
The above data is expressed graphically in figure 7 in the following way. There are
17 wounds and each wound has been assessed 4 times after the initial time zero
assessment. This means that we have 68 individual time points to assess the
appearance of the dressing at. This is shown in figure 7.
Appearance of Dressing 1 = As applied
2 = Partially adhered
3 = Dressing not insitu
4 = Dressing Desiccated
-
In Control Cambridge Ltd
16
Figure 7.
The data shows that the dressing performed well in that it was mostly as applied
when inspected or partially adhered to the wound as shown as demonstrated in a
few of the cases.
-
In Control Cambridge Ltd
17
Wear Time of Dressing
The dressing wear time in days was assessed and the results are shown in table 8.
Table 8
Patient 1 week 2 week 3 week 4 week
FF 7 3 5 4
HP 3 7 7 7
JM 2 3 3 3
JM2 4 7 4 4
KS 3 3 3 4
MH 4 3 3 7
RM 3 7 7 7
AK1 4 4 4 4
AK2 4 4 4 4
AS 4 4 2 2
DM 7 7 4 6
EE 3 7 3 7
ES 3 4 7 7
GM1 7 7 4 4
GM2 7 7 4 4
PR 7 7 4 7
SD 5 7 7 7
The results are expressed graphically in figure 8. There are 17 wounds and each
wound has been assessed 4 times after the initial time zero assessment. This
means that we have 68 individual time points to assess the wear time of the
dressing.
Figure 8.
The majority of dressings in this study were changed at 3, 4 and 7 days.
-
In Control Cambridge Ltd
18
pH Values
The pH level of a wound can be a clinical indication to healing. During this study simple litmus paper was applied to the wound fluid at dressing changes. A pH of 7 represents neutral; a pH below 7 is acidic representing a higher hydrogen concentration, while a pH value above 7 is termed base or alkaline and represents a lower hydrogen concentration. The pH values were assessed at each time point and are shown in table 9. Table 9. pH values at each assessment point
Patient Time 0 1 week 2 week 3 week 4 week
FF 8 8 8 8 8
HP 8 8 8 8 8
JM 8 8 8 8 8
JM2 8 8 7 8 8
KS 8 8 7 8 7
MH 8 8 8 8 8
RM 8 8 8 8 8
AK1 8 8 8 8 8
AK2 8 8 8 8 8
AS 8 8 8 8 7
DM 7 7 7 8 8
EE 8 8 8 8 7
ES 8 8 8 8 8
GM1 8 8 8 8 8
GM2 8 8 8 8 8
PR 8 8 8 8 8
SD 8 8 8 8 7
The results show that there was not too much change in pH value with most being
just above neutral.
-
In Control Cambridge Ltd
19
Wound Healing Continuum
The wound healing continuum is a recognised tool as a way of identifying the colours present in any given wound (3) and applying the most significant colour to the spectrum e.g. black defining necrosis through to pink healthy epithelisation. The results are shown in table 10. Table 10.
Patient Time 0 1 week 2 week 3 week 4 week
FF 4 4 4 4 4+6
HP 4 4 4 4 4
JM 5 3 + 6 3 + 6 6 6
JM2 4 4 4 4 6
KS 3 4 4 3 + 6 3 + 6
MH 4 4 4 6 7
RM 3 3 4 7 Closed
AK1 3 3 4 4 6
AK2 4 5 5 5 6
AS 3 3 3 + 6 3 + 6 3 + 6
DM 5 4 6 6 6
EE 3 4 3 + 6 3 + 6 3 + 6
ES 5 5 5 6 7
GM1 2+5 2+5 5 5 2+5
GM2 5 4 5 5 2 + 6
PR 4 4 4 3 + 6 6
SD 6 6 6 6 6
Key: The results are expressed graphically in figure 9.
Wound continuum 1 = Black
2 = Black / yellow
3 = Yellow
4 = Yellow / red
5 = Red
6 = Red / pink
7 = Pink
-
In Control Cambridge Ltd
20
Figure 9a
Figure 9b
The results show that at the start of the study most wounds were around the yellow to red zone, whereas at the end of the study the graph shows a movement to the right which puts the majority of the wounds in the Red/Pink zone. This indicates that the majority of the wounds were progressing towards healing throughout this study.
-
In Control Cambridge Ltd
21
Samples of Patient Photographs Demonstrating Effectiveness of KerraContact Ag
The following section shows some samples of wound photographs taken during this study. Example 1 – RM
Time 0 1 week
2 week 3 week
4 week
-
In Control Cambridge Ltd
22
Example 2 – RM
Time 0 1 week
2 week 3 week
4 week
-
In Control Cambridge Ltd
23
Example 3 – PR
Time 0 1 week
2 week 3 week
4 week
-
In Control Cambridge Ltd
24
Example 4 – HP
Time 0 1 week
2 week 3 week
4 week
-
In Control Cambridge Ltd
25
Conclusion
This study has produced positive results demonstrating that KerraContact Ag both stimulates healing, as shown in the wound area data, and also reduces the signs of infection, as demonstrated in the other assessments.
The management of chronic wounds represents a significant burden, not only in terms of direct costs to healthcare services (4) but in terms of patient safety and quality of life. The management becomes an even greater problem when bacteria are present in wounds as this can have a negative impact on healing. At the same time there is concern over the increase of multi-resistant bacteria in wound care (5). Silver has been used for medicinal purposes for thousands of years and is once again gaining popularity due, in part, to the rise of these multi-resistant strains (6).
The objective in managing infected venous ulcers is to reduce the signs and symptoms of infection allowing compression to treat the underlying cause. The results of this study indicate that KerraContact is having this effect.
References
1. Graham ID, Harrison MB, Nelson EA, Lorimer K, Fisher A. (2003). Prevalence of a lower-limb ulceration: a systematic review of prevalence studies. Adv. Skin Wound Care 16(6): 305-316.
2. Cutting KF (2008) Should evidence dictate clinical practice, or support it? J
Wound Care 17(5): 216
3. White RJ (2002) The wound infection continuum. Br.J Nurs 11(22 Suppl): 7–9
4. Vanscheidt W., Lazareth I, Routkovsky-Norval C. (2003) Safety Evaluation of a new ionic silver dressing in the management of chronic ulcers. Wounds 15(11):371-378
5. Graham C. (2005). The role of silver in wound healing. BJN 14(19):S22, S24, S26
6. Driver VR (2004). Silver dressings in clinical practice. Ostomy Wound Management. 50(9A): 11s-15s.