Comparative Pilot study of Chemspunge® and Comfeel dressings
 for venous stasis ulcers over a period of eight weeks

Author: Johan Francois Coetzee,  MBchB. Medical Officer,  Swartland Hospital, Malmesbury,  Western Cape, South Africa.

Introduction:
Venous stasis ulcers usually incur a long period of chronicity,  often lingering for several years with little hope of complete healing.  This brings about high costs to the healthcare system in terms of materials used and personal time.  Customary treatments involve pressure stockings and dressings that require frequent renewal.  The former are often a source of patient discomfort and the latter tend to leakage,  causing inconvenience and embarrassment.  Often this treatment is substituted for mere antibacterial cream and paraffin gauze dressing.  Frequent visits to healthcare clinics are therefore often necessary,  limiting patients' prospects for obtaining employment.

Several wound products for treatments of stasis ulcers are available and are used with varying degrees of success.  Layered compression therapy,  in which four layers of bandages are applied,  is regarded as the gold standard therapy for venous stasis ulcers.

Unfortunately these products are often reckoned to be too expensive for use in state hospitals and at present most health professionals use colloid dressing as an alternative.  The Standard Treatment Guidelines & Essential Drug List for South Africa (EDL) suggests topical cleansing,  paraffin gauze dressings and use of hydrocolloid dressing for complicated leg ulcers.

A complicated leg ulcer according to the EDL's definition is a chronic and relapsing wound with venous insufficiency.  Recently a new product,  Chemspunge® Wound Dressings,  based upon hydrophilic silica granules enclosed in a porous bag has been found to promote healing of chronic pressure ulcers and septic burn wounds.

Purpose of the study:
The purpose of the study will be to determine whether application of the Chemspunge® Wound Dressings system assists in the healing of chronic venous stasis ulcers and whether it is cost effective when compared to a standard system that is generally employed in the State healthcare establishment (Comfeel® from Coloplast).

The hypothesis stated that usage of the Chemspunge® Wound Dressings product would:
  • Facilitate and accelerate wound healing.
  • Cause less patient discomfort and social embarrassment.
  • Lead to a higher success rate of complete healing.
  • Lead to lower treatment costs.
Methods:
Eleven patients with chronic venous stasis leg ulcers were randomly selected to receive either therapy. Chemspunge® Wound Dressings were applied to patients 1, 3, 5, 7, 9, 11 and Comfeel was applied to patients 2, 4, 6, 8 and 10.

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Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Patient 11
After four weeks and after eight weeks of treatment the patients of both groups were asked the following questions:

        1. Does your wound appear to be better after four weeks?  Yes or No.
        2. Do you have more pain or less pain?
        3. Do you need pain medication?
        4. How do you feel about the treatment,  happy,  neutral or unhappy?

After two weeks of therapy,  the wounds were evaluated for redness,  pain,  maceration odour, tenderness,  necrotic tissue,  over granulation,  pus and amount of exudation.  A score out of 10 was given once a week.  (See the table 1).  Each finding counted 1 point,  and a high score indicates that a wound is in a poor condition.

Surrounding skin:

1. Redness 
2. Tenderness 
3. Maceration 

Pain  /10
Necrotic tissue 
Over Granulation 
Odour 
Pus 

Exudate: absent (dry)  , of
Moist , of
Excessive (leaks through the dressings) .

Total score for wound evaluation:





Wound evalution form

Table 1

( /1)
( /1)
( /1)

( /1)
( /1)
( /1)
( /1)
( /1)

( /0)
( /1)
( /2)

( /10)
Wound surface area:  At the end of each week all the patients' wounds were photographed using a digital camera.  A customized computer program to estimate the wound surface areas was used to note any changes in the wound surface area during the eight weeks of treatments.

Statistical analysis:
A computer software package was used to perform the statistical analysis  (Sigmastat for Windows version 2.03, SPSS Inc.,  USA).  Within-group comparisons were done using repeated measures analysis of variance.  Between group comparisons were done using t-tests and if the data did not meet the criteria for normality of distribution and equivalence of variances,  non parametric tests  (Mann-Whitney)  tests were performed.  Proportional data were analysed using the Fisher exact test.  An alpha value of 0.05 or less was accepted as indicating statistical significance.

Results:
The ages of the patients ranged from 35 years to 88 years and the man 58 years.  The duration of the wounds ranged from 6 months to 37 years,  the mean duration was 11 years.  Body-mass indexes of the patients ranged from 22.1 to 51.3,  the mean body-mass index was 33.3.  Normally body-mass index is regarded as a value between 20 and 24.  Ankle Brachial indexes ranged from 0.85 to 1,  the mean was 0.94.  The normal value for the ankle brachial index is 1 and is determined by dividing the systolic blood pressure ankle by the systolic blood pressure of the brachial artery.

Of the Chemspunge® Wound Dressings group five patients indicated they thought the wounds appeared better and one indicated that it looked worse.  Four patients had less pain and two had more pain.  Three patients required pain medication and three did not.  Three patients were satisfied with their treatment,  one was neutral and two were not satisfied.

Of the Comfeel® group two patients thought that their wounds were worse and one patient indicated that the wound was better.  All three patients said that they had more pain and all of them needed analgesics.  Two patients were unsatisfied with their treatment and the third patient was neutral about the treatment.

The following findings were noted during the eight weeks of treatment:
After two weeks patient number 8 developed an allergic reaction to the Comfeel® and the wounds became severely infected.  The leg was very painful with maceration of the surrounding skin.  The dressing was changed to Chemspunge® Wound Dressings and the patient was admitted for intravenous antibiotics.  The patient was discharged after 7 days and will be followed up as an outpatient.

The wound of the patient number 10 healed within the first week.  This was a small wound that had been present for only four weeks before initiating therapy.  It was therefore not chronic stasis ulcer,  as it had not been present for more then six weeks.

There were 6 patients in the Chemspunge® Wound Dressings group and 3 patients in the Comfeel® group who completed the eight-week study.  Results are presented n table 1.  Wound areas were compared at 1,4 and 8;  pain scores at weeks 2,4 and 7;  wound scores at weeks 2,4 and 8.  There were no significant differences,  either within the groups or between the groups.  The Fisher exact test indicated that there was no difference between the groups in the proportions of patients who experienced less pain at the end of the study period (p=0.46).

Table 2: Results of within-groups and between-groups comparisons:

Week

Chemspunge® Wound Dressings

Comfeel®
P#
(95%CI)
0.87
( -- 40 to 34)
27
(35)
24
(14)
1

2

p*

28
(22)
8

47
(46)
0.21
0.15
0.83
( -- 48 to 34)
0.83
( -- 71 to 31)
33
(21)
37
(34)
Wound suface area (cm²)

(mean,(SD))

0.095
7
(5 - 5.7)
5
(0 - 5)
2

p*

4.5
(4 - 5)
6
(6 - 8.25)
0.433
0.94
0.29
4
(2 - 6)
6
(6 - 7.5)
Wound suface area (cm²)

(Median,
 (25% - 75%))

4

0.095
7

*= Repeated measures analysis of variance.
#= Between-group comparisons.
95% CI= 95% confidence interval of the difference between means.

Discussion:
From table 2 it there appears to be a trend towards more rapid improvement of the ulcers of the Chemspunge® Wound Dressings group.  However the group sizes were too small to achieve statistical significance as indicated by the large standard deviations and 95% confidence intervals of the differences between the means of the groups.  Based on the wound area data obtained at week-8,  to achieve 80% power at an alpha value of 0.05,  a total sample size of 47 would be required.  It is therefore recommended that the study be expanded to sample sizes of 25 patients per group.
The information collected in this pilot study should serve as a useful guideline for further trails.  Many obstacles were encountered that limited the validity of the data collected.  Some of these obstacles included the following:
1. We could not apply strict exclusion criteria due to the limited numbers of patients with stasis ulcers in our district.
2. Fourteen people (instead of one person) were involved in collecting the wound score data due to frequent changes in the staff in the casualty department.
3. We could not change the dressings on a daily basis when needed because the patient could only attend clinics three times a week due to transport limitations.
If one considers that the mean age of the wounds are eleven years at the time of the study it is likely that a longer study would be more appropriate.  It is obvious from the statistical analysis that a larger group of patients should be recruited for a study like this to make meaningful statistical analysis possible.  One should also note that most of the patients were not good candidates for wound healing, since most of them were overweight and elderly.  The lack of significant improvement of the wound surface areas is most likely due to the fact that the cause of the wounds,  venous stasis,  was not addressed.  None of the patients used pressure stockings during the study.

Certain observations are worth mentioning:
Although twice the number of patients were treated with Chemspunge® Wound Dressings,  no allergic reactions were noted.
Chronic pain is a significant problem in the treatment of venous stasis ulcers.  Fifty percent of all study experienced increased pain during their treatment and sixty percent needed pain medication.
Fifty percent of Chemspunge® Wound Dressings group were satisfied with their treatment although the wound sores of the Chemspunge® Wound Dressings group did not change.  This is probable related to a decrease in pain experienced by the patients.
None of the Comfeel® patients were satisfied with their treatment,  and the entire Comfeel® group needed pain medication.  Although minor changes of the wound scores were seen in most patients in both groups, it appears that Chemspunge® Wound Dressings dressings are a more acceptable treatment to patients due to a decrease in pain.

Conclusion:
Venous stasis ulcers continue to be one of the most difficult wounds to treat successfully since the most efficient treatments are often too expensive or unacceptable for the patients involved.  The effective treatment of pain in these patients should also be a priority of the clinician involved in treating these patients.  The treatment of venous stasis ulcers is a clinical problem which is poorly researched and much more research should be done to find a better solutions for patients who suffer from this condition.

References:
i Cullum, N., Fletcher, A., and Shelden, T. A systematic review of compression treatment for venous leg ulcers. BMJ. 315(6), 576-580.
ii The Standard Treatment Guidelines and Essential Drugs List for Adults at Hospital level,  1998 edition.  Page 105 (Copies may be obtained from:  The Directorate: Pharmaceutical Programs and Planning,  Private Bag X 828,  Pretoria,  001)

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