EWMA 2013 - Ep497 - Evidence Based Assessment of Moist Wound Healing Dressings: In vitro, In vivo...

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Patrick Brosnan, Alexander Waite, Jim Mellor, Breda Cullen, Systagenix, Gargrave, UK.

Transcript of EWMA 2013 - Ep497 - Evidence Based Assessment of Moist Wound Healing Dressings: In vitro, In vivo...

Page 1: EWMA 2013 - Ep497 - Evidence Based Assessment of Moist Wound Healing Dressings: In vitro, In vivo and Clinical

Aim

Methodology

The evidence hierarchy

Total Fluid Handling; in Vitro

Evidence Based Assessment of Moist Wound Healing Dressings: 

In vitro, In vivo and ClinicalPatrick Brosnan, Alexander Waite, Jim Mellor, Breda Cullen, Systagenix, Gargrave, UK.

EP497EWMA May 2013C1385‐4

IntroductionClinically supportive evidence provides thebasis for selection and correct use of woundcare products. Different types of supportivedata are available including; in vitro / in vivolaboratory studies, reviews, case reports,clinical evaluations and randomised clinicaltrials (RCT). However there is debate over whatqualifies as sufficient evidence to make aninformed decision concerning dressingselection.

Clinical Trial

Non‐Comparative Clinical Evaluation

Conclusion

Results

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013 Aim

nvestigation sets out to conduct a comprehensive review of published clinicallyrtive evidence underpinning a hydropolymer foam wound dressing* and tomine the clinical relevance of the in vitromodel.

Methodology

s study we review the strength of evidence available for a hydropolymer moistd healing dressing. There is a clear hierarchy of supportive data:1: RCT2: Case studies/series and clinical assessment3: Laboratory based in vitro and in vivo analysisdition we looked to see if data generated in vitro could be confirmed in clinicalce and if models used to assess dressings in vitro are clinically relevant.

Results

ce is available from multiple levels from laboratory based analysis to RCTs. Althoughare deemed to hold the highest clinical significance, it is important also towledge the significance of non‐clinical evidence that although not clinically sourced

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013 The evidence hierarchy:A Moist Wound Healing Dressing

Lab Studies‐in vitro, in vivo, ex vivo

Editorials, opinions

Case series, Case studies

Cohort studies, Clinical research

Clinical Trials

Meta analyses

Level 3

Level 2

Level 1

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013 Total Fluid Handling; in Vitro

uid handling of moist wound healing dressings  is defined as both the absorbent ty and the moisture vapour transmission rate (MVTR) and can be assessed using the Standard Paddington Cup Test Method (BS:EN 13726).

3) After storage the apparatus is weighed again, weight = y

2) The “Paddington Cup” with sample + 

water is weighedweight = x

4) Water is drained and the 

apparatus weighedweight = b

MVTR = x‐y /storage time/ areaAbsorbent Capacity = b‐a /storage time/ areaTotal Fluid Handling = MVTR + Absorbent Capacity

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013 Total Fluid Handling; in Vitro (continued)

 fluid handling of the hydropolymer dressing was shown to be greater than that of other foam dressings

14,392

4,302 4,336

3,880

9,15910,312

02000400060008000100001200014000160001800020000

TIELLE Plus with Comfort Foam Allevyn Adhesive Allevyn Gentle Border

(g/m

2 /24h)

MVTR Absorbent Capacity

Hydropolymer Dressing* Foam Dressing 1 Foam Dressing 2

Results

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013The prevention of Heel Pressure Ulcers 

Using a Hydropolymer Dressing in Surgical Patients; Clinical Trial.ots, T.C.M. &  Apotheker, B.F.G. Journal of Wound Care 2004, 13(9), 375‐378

m of the study was to investigate whether  a hydropolymer foam dressing* could  the prevalence of heel pressure ulcers during hospital stay and following surgery.

rgical patients were split into two groups depending on risk assessment and on of surgical procedure;1: Hydropolymer dressing (surgery >90min & high risk patient)2: No hydropolymer dressing (surgery <90min & lower risk patient)

Aim

Resultss study the number of group 1 (from 117 patients) that developed a heel ulcers was  .5%).ate of heel ulcer formation in similar patients prior to preventive measures was %. This equates to a 76.7% reduction.

tive care with a hydropolymer  dressing and education can greatly reduce the f h l l f i

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013A Non‐Comparative Multicentre Clinical Evaluation 

of a New Hydropolymer Adhesive DressingA., Lane, C., Walsh, J., Whittaker, S., Ballard, K., Young, S.R. J Wound Care 1999, 8(10):489‐492.dy evaluates the performance of a non‐adherent hydropolymer dressing* in acute and chronic s, in the presence of bleeding and/or low exudate, with respect to adherence to the wound 

ents (75 wounds) were recruited in a multicentre, non‐comparative 4‐week clinical study, g 32 chronic wounds and 43 acute wounds with the non‐adherent hydropolymer dressing .

parameters were measured at each dressing change.

Results

The non‐adherent hydropolymer dressing was considered pain‐free and easy to remove, correlating with low incidence of adherence to the wound bed.

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013Conclusion

gh critical appraisal of the combined published evidence both in vitro and in vivo we rive a better overall understanding of how a dressing or material performs. In on different variants of a material may provide distinct benefits which may be more priate for different clinical situations. This suggests that all available evidence should sidered  to facilitate more appropriate dressing selection.