Ivins Nicola, Harding Keith

1. Results from a pilot, randomised, controlled clinical trial
on the efficacy of Kendall AMD™ (antimicrobial foam
dressing) compared with Allevyn Ag™ (hydrocellular
antimicrobial foam dressing) in the reduction in size,
change in bioburden and wound biochemistry of hard-
to-heal chronic venous leg ulcers
Ivins N (MSc RGN), Hagelstein S M (Dip in Nursing RGN NDN), Walkley N A (BSc
PhD), Mudge E J (SRCh MChS BSc MSc), Professor K G Harding (CBE FRCGP FRCP
FRCS). Wound Healing Research Unit Cardiff
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2. Introduction
Infection is the single, most important independent factor which delays
healing of acute and chronic wounds, yet the management of wound infection
remains challenging. Antibiotics have been associated, through misuse and
over-use, with the appearance and rise in resistant (notably Methicillin
Resistant Staphylococcus aureus) and emergent organisms (notably
Clostridium difficile infection)1. Conversely, antiseptics are not associated with
this risk of resistance or emergence but have been judged by many clinicians
to be toxic for open wounds² yet few meaningful clinical trials have measured
the value of topical antiseptics in wound care3.
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References:
1. European Wound management Association Position Documents. Identifying criteria for wound infection.
Management of wound infection London. Medical Education Partnership. 2005
2. O’Meara SM, Cullum NA, Majid M, Sheldon TA. Systematic review of antimicrobial agents used for chronic
wounds. British Journal of Surgery 2001; 88:4-21
3. O’Meara S, Al-Kurdi, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database of
Systematic Reviews 2008; Issue 1: CD003557

3. Aims & Method
The primary objective of the study was to compare two foam dressings
Kendall AMD™ (which contains PHMB) and Allevyn Ag™ (which contains
silver) by showing a reduction in ulcer size over a 12 week period. The
secondary objectives were change in bacterial bio-burden, wound
biochemistry, pain, odour and level of exudate.
The study was conducted over a 12 week period or until healing (defined by
100% epithelialisation of the target ulcer) whichever occurred sooner.
Dressings were changed and the treatment repeated every 3 days (± 1-2
days). Clinical, microbiological, biochemistry, planimetric and photographic
assessments were conducted on days 0, 7, 14, 28, 56 and 84. The efficacy of
each dressing was evaluated. Apart from the difference in the primary wound
dressing, subjects in each group were subjected to the same treatment
procedures.
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4. Results
Data analyses were conducted on 32 evaluable patients (16 patients in each
arm). A total of 11 (34.8%) patients healed or re-epithelialised within the 12
week intervention phase, 7 (63.64%) from the Kendall AMD group and 4
(36.6%) from the Allevyn Ag™ group.
A total of 23 bacterial organisms were identified. 8 patients showed a 2 log
decrease in bioburden. Not all of the biological factors analysed were present
in detectable levels in the wound fluid samples. There were no obvious
differences observed between the levels of the studied biological factors with
either treatment group or whether the wound had healed exudate levels
reduced.
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1a 1b 2a 2b
Figures showing the wounds of two patients (1 & 2) treated with Kendall AMD™ foam dressing at the initial and final visit and also
Healing by treatment group.

5. Conclusion/Discussion
There is evidence from this to suggest that Kendall AMD™ foam dressing is an
efficient wound management product for hard-to-heal leg ulcers.
Further research is required to explore the incidence of healing on a larger
study population and to further explore the efficacy of Kendall AMD™ foam
dressing against other modalities of ulcer care.
This study provided good evidence to show that Kendall AMD™ antimicrobial
foam dressing had positive healing outcomes for some patients and the study
treatment was well tolerated by the patients overall and the level of
satisfaction with the treatment was also high.
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