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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
WHRU CARDIFF 1
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.
WHRU CARDIFF 2
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
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.
WHRU CARDIFF 3
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.
WHRU CARDIFF 4
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.
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.
WHRU CARDIFF 5

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EWMA 2014 - EP499 MANAGEMENT OF AN INFECTED DIABETIC FOOT WITH SPECIALIZED DR...EWMA 2014 - EP499 MANAGEMENT OF AN INFECTED DIABETIC FOOT WITH SPECIALIZED DR...
EWMA 2014 - EP499 MANAGEMENT OF AN INFECTED DIABETIC FOOT WITH SPECIALIZED DR...
 
EWMA 2014 - EP498 USE OF NEGATIVE PRESSURE THERAPY IN CONJUNCTION WITH A PROT...
EWMA 2014 - EP498 USE OF NEGATIVE PRESSURE THERAPY IN CONJUNCTION WITH A PROT...EWMA 2014 - EP498 USE OF NEGATIVE PRESSURE THERAPY IN CONJUNCTION WITH A PROT...
EWMA 2014 - EP498 USE OF NEGATIVE PRESSURE THERAPY IN CONJUNCTION WITH A PROT...
 
EWMA 2014 - EP496 CONTEMPORARY SILVER DRESSINGS IN THE TREATMENT OF INFECTED ...
EWMA 2014 - EP496 CONTEMPORARY SILVER DRESSINGS IN THE TREATMENT OF INFECTED ...EWMA 2014 - EP496 CONTEMPORARY SILVER DRESSINGS IN THE TREATMENT OF INFECTED ...
EWMA 2014 - EP496 CONTEMPORARY SILVER DRESSINGS IN THE TREATMENT OF INFECTED ...
 
EWMA 2014 - EP495 TOTAL CONTACT CASTING – A SOUTH AFRICAN APPROACH TOWARDS OF...
EWMA 2014 - EP495 TOTAL CONTACT CASTING – A SOUTH AFRICAN APPROACH TOWARDS OF...EWMA 2014 - EP495 TOTAL CONTACT CASTING – A SOUTH AFRICAN APPROACH TOWARDS OF...
EWMA 2014 - EP495 TOTAL CONTACT CASTING – A SOUTH AFRICAN APPROACH TOWARDS OF...
 
Ep4EWMA 2014 - EP493 GAIT ALTERATIONS AND MICROVASCULAR CHRONIC COMPLICATIONS...
Ep4EWMA 2014 - EP493 GAIT ALTERATIONS AND MICROVASCULAR CHRONIC COMPLICATIONS...Ep4EWMA 2014 - EP493 GAIT ALTERATIONS AND MICROVASCULAR CHRONIC COMPLICATIONS...
Ep4EWMA 2014 - EP493 GAIT ALTERATIONS AND MICROVASCULAR CHRONIC COMPLICATIONS...
 
EWMA 2014 - EP492 PREVALENCE OF DIABETIC RETINOPATHY (DR) AND ITS CORRELATION...
EWMA 2014 - EP492 PREVALENCE OF DIABETIC RETINOPATHY (DR) AND ITS CORRELATION...EWMA 2014 - EP492 PREVALENCE OF DIABETIC RETINOPATHY (DR) AND ITS CORRELATION...
EWMA 2014 - EP492 PREVALENCE OF DIABETIC RETINOPATHY (DR) AND ITS CORRELATION...
 
EWMA 2014 - EP491 DETECTION OF RISK FACTORS CONCERNING DIABETIC FOOT (DF) THR...
EWMA 2014 - EP491 DETECTION OF RISK FACTORS CONCERNING DIABETIC FOOT (DF) THR...EWMA 2014 - EP491 DETECTION OF RISK FACTORS CONCERNING DIABETIC FOOT (DF) THR...
EWMA 2014 - EP491 DETECTION OF RISK FACTORS CONCERNING DIABETIC FOOT (DF) THR...
 
EWMA 2014 - EP490 THE CHARACTERISTICS OF WOUND PAIN ASSOCIATED WITH DIABETES-...
EWMA 2014 - EP490 THE CHARACTERISTICS OF WOUND PAIN ASSOCIATED WITH DIABETES-...EWMA 2014 - EP490 THE CHARACTERISTICS OF WOUND PAIN ASSOCIATED WITH DIABETES-...
EWMA 2014 - EP490 THE CHARACTERISTICS OF WOUND PAIN ASSOCIATED WITH DIABETES-...
 
EWMA 2014 - EP489 PERIPHERAL ARTERIAL DISEASE IN DIABETIC PATIENTS WHO NEED A...
EWMA 2014 - EP489 PERIPHERAL ARTERIAL DISEASE IN DIABETIC PATIENTS WHO NEED A...EWMA 2014 - EP489 PERIPHERAL ARTERIAL DISEASE IN DIABETIC PATIENTS WHO NEED A...
EWMA 2014 - EP489 PERIPHERAL ARTERIAL DISEASE IN DIABETIC PATIENTS WHO NEED A...
 
EWMA 2014 - EP488 THE COMBINATION OF THE HYDROACTIVE OINTMENT BANDAGE* AND TH...
EWMA 2014 - EP488 THE COMBINATION OF THE HYDROACTIVE OINTMENT BANDAGE* AND TH...EWMA 2014 - EP488 THE COMBINATION OF THE HYDROACTIVE OINTMENT BANDAGE* AND TH...
EWMA 2014 - EP488 THE COMBINATION OF THE HYDROACTIVE OINTMENT BANDAGE* AND TH...
 
EWMA 2014 - EP487 KIDNEY-FOOT SYNDROME: OUTCOMES AFTER PTA IN EP487 KIDNEY-FO...
EWMA 2014 - EP487 KIDNEY-FOOT SYNDROME: OUTCOMES AFTER PTA IN EP487 KIDNEY-FO...EWMA 2014 - EP487 KIDNEY-FOOT SYNDROME: OUTCOMES AFTER PTA IN EP487 KIDNEY-FO...
EWMA 2014 - EP487 KIDNEY-FOOT SYNDROME: OUTCOMES AFTER PTA IN EP487 KIDNEY-FO...
 
EWMA 2014 - EP486 THE USE OF BIOSYNTHETIC BANDAGES «HYDROBALANCE-BANDAGE» (HB...
EWMA 2014 - EP486 THE USE OF BIOSYNTHETIC BANDAGES «HYDROBALANCE-BANDAGE» (HB...EWMA 2014 - EP486 THE USE OF BIOSYNTHETIC BANDAGES «HYDROBALANCE-BANDAGE» (HB...
EWMA 2014 - EP486 THE USE OF BIOSYNTHETIC BANDAGES «HYDROBALANCE-BANDAGE» (HB...
 
EWMA 2014 - EP485 EVALUATION OF MR ANGIOGRAPHY RESULTS IN DIABETIC FOOT PATIENTS
EWMA 2014 - EP485 EVALUATION OF MR ANGIOGRAPHY RESULTS IN DIABETIC FOOT PATIENTSEWMA 2014 - EP485 EVALUATION OF MR ANGIOGRAPHY RESULTS IN DIABETIC FOOT PATIENTS
EWMA 2014 - EP485 EVALUATION OF MR ANGIOGRAPHY RESULTS IN DIABETIC FOOT PATIENTS
 
EWMA 2014 - EP483 THE EFFECTS OF DIABETIC FOOT ULCER (DFU) WOUND FLUID PH ON ...
EWMA 2014 - EP483 THE EFFECTS OF DIABETIC FOOT ULCER (DFU) WOUND FLUID PH ON ...EWMA 2014 - EP483 THE EFFECTS OF DIABETIC FOOT ULCER (DFU) WOUND FLUID PH ON ...
EWMA 2014 - EP483 THE EFFECTS OF DIABETIC FOOT ULCER (DFU) WOUND FLUID PH ON ...
 
EWMA 2014 - EP482 COMPARISON OF ANGIOGRAPHIC FINDINGS BETWEEN PATIENTS WITH N...
EWMA 2014 - EP482 COMPARISON OF ANGIOGRAPHIC FINDINGS BETWEEN PATIENTS WITH N...EWMA 2014 - EP482 COMPARISON OF ANGIOGRAPHIC FINDINGS BETWEEN PATIENTS WITH N...
EWMA 2014 - EP482 COMPARISON OF ANGIOGRAPHIC FINDINGS BETWEEN PATIENTS WITH N...
 
EWMA 2014 - EP477 EVALUATION OF FOOT SELF CARE KNOWLEDGE AND PRACTICES IN SAU...
EWMA 2014 - EP477 EVALUATION OF FOOT SELF CARE KNOWLEDGE AND PRACTICES IN SAU...EWMA 2014 - EP477 EVALUATION OF FOOT SELF CARE KNOWLEDGE AND PRACTICES IN SAU...
EWMA 2014 - EP477 EVALUATION OF FOOT SELF CARE KNOWLEDGE AND PRACTICES IN SAU...
 
EWMA 2014 - EP476 DIABETIC FOOT ULCER HEALING IN RELATIONSHIP WITH INITIAL TR...
EWMA 2014 - EP476 DIABETIC FOOT ULCER HEALING IN RELATIONSHIP WITH INITIAL TR...EWMA 2014 - EP476 DIABETIC FOOT ULCER HEALING IN RELATIONSHIP WITH INITIAL TR...
EWMA 2014 - EP476 DIABETIC FOOT ULCER HEALING IN RELATIONSHIP WITH INITIAL TR...
 
EWMA 2014 - EP475 ANALYSIS OF MICROBIOTA IN DIABETIC FOOT ULCERS IN RELATION ...
EWMA 2014 - EP475 ANALYSIS OF MICROBIOTA IN DIABETIC FOOT ULCERS IN RELATION ...EWMA 2014 - EP475 ANALYSIS OF MICROBIOTA IN DIABETIC FOOT ULCERS IN RELATION ...
EWMA 2014 - EP475 ANALYSIS OF MICROBIOTA IN DIABETIC FOOT ULCERS IN RELATION ...
 

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Ewma 2014 ep399 results of a pilot, randomised, controlled clinical trial on the efficacy of an antimicrobial foam dressing compared with hydrocel

  • 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 WHRU CARDIFF 1
  • 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. WHRU CARDIFF 2 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. WHRU CARDIFF 3
  • 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. WHRU CARDIFF 4 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. WHRU CARDIFF 5