Performance Characterisation of a New Foam Cover Dressing Dave Pritchard , Lewis Jones , Claire Brewer , Steve Bishop , Helen Shaw and Christine Cochrane 1 1 1 1 1 1 2 ConvaTec GDC, Deeside, Flintshire CH5 2NU; 2Dept. Veterinary Clinical Science, University of Liverpool Introduction • Contouring to an in vitro Simulated Wound Tissue Model Foam dressings have been used successfully on a wide range of exuding wounds for many years. A new design of foam cover dressing has now been developed, with unique performance characteristics. This new foam cover dressing’s performance characteristics have been measured through the performance of a range of in-vitro laboratory tests, in order to determine the potential advantages which may be offered by this new design of dressing. Methods & Results The following dressing performance characteristics have been assessed within this in-vitro study: A small hole was placed in the wall of a Petri dish. A section of pork belly (approximately 5cm x 1cm x 1cm) was used as a simulated wound bed and placed inside along the wall of the Petri dish. A section of the dressing was then placed over the pork belly. The dressings were secured in place with adhesive tape. A 21 gauge syringe needle was then inserted at a 45° angle through the pork belly and the hole in the Petri dish, until it had been pushed through to the simulated wound bed surface, just underneath the dressing’s wound contact surface. A Microjet Micro pump was set to dispense 4.3ml/hour of 0.01% (w/v) o-Toluidine Blue dye in Solution A (Calcium Chloride & Sodium Chloride Test Solution BP) through the syringe needle. Images of this set up were captured every 20 seconds during the test, using a QImaging digital camera, until the sample was fully hydrated. New Foam • Fluid Retention Under Compression Force As the Hydrofiber® layer absorbed fluid and formed a cohesive gel, intimate contact with the simulated wound bed was observed. The fluid was then observed to wick into the foam layer. This technique, based on standard Pharmacopoeia method (BP 1993, Volume II, Appendices, A222, Appendix XX, T. Water-retention Capacity) measures the fluid absorbed and retained by dressings whilst using different loads to simulate varying levels of compression. The fluid absorbency and retention under a load equivalent to 40mmHg pressure was measured for each dressing. Pre Hydration Absorbency (g/g/24hrs) Retention (g/g/24hrs) New Foam 7.30 ± 0.26 [6.96 – 7.85] 6.92 ± 0.23 [6.58 – 7.50] Foam A 3.50 ± 0.08 [3.43 – 3.59] 3.39 ± 0.08 [3.32 – 3.47] Foam B 5.19 ± 0.20 [5.06 – 5.41] 4.89 ± 0.21 [4.74 – 5.13] Post Hydration Foam A Foam A dressing was observed to not completely conform to the simulated wound bed even when the dressing had absorbed fluid (see arrows). Pre Hydration Post Hydration Foam B Table 1. Foam B dressing was observed to not completely conform to the simulated wound bed even when the dressing had absorbed fluid (see arrows). Absorbency/Retention Under Compression 8 Absorbency (g/g) Retention (g/g) 7 6 g/g 5 Pre Hydration 4 3 Post Hydration Figure 3. 2 • Bioadhesion Studies 1 0 New Foam Foam A Foam B Figure 1. • Directional Spread of Fluid Across the Wound Contacting Layer A plastic 50ml Terumo syringe was cut so that the bottom (dispensing end) half of the syringe was removed to form an open-ended plastic vial of 29.2mm open diameter. This vial was positioned in the centre of the wound contact layer of the test dressing and held in place. 20ml of simulated exudate (horse serum) was injected into the vial. Once the full content of the vial had been expelled, the stopwatch was started. When 60 seconds had elapsed, any non-absorbed fluid was removed from the vial using an intact syringe. The plastic vial was then removed. A metal rule was placed underneath the dressing and a photograph was taken of both dressing and rule using a digital camera. Once all photographs had been taken, the area of lateral fluid spread was measured using image analysis software. The lateral spread, expressed as a % of the original “wound” area was calculated as follows: Fibroblasts were cultured from debrided tissue which was immediately transferred into a sterile dish containing Hank’s balanced salt solution (HBSS). The tissue was washed and cut into small (3–5mm2) pieces which were then placed into 25cm2 tissue culture flasks containing media (Dulbecco’s Modified Eagle Medium (DMEM), supplemented with 10% foetal calf serum (FCS) (Sigma, UK), 20 mM Hepes buffer, 100μg/ml gentamicin and 0.5μg/ml amphotericin B). Cell cultures were incubated at 37°C in a 5% CO2/95% air environment. Readiness for sub-culturing was determined by the extent of fibroblast cell outgrowth (5–10 days). Cells were farmed successively in a 1:4 split ratio to passage 3–8 before experimental use. Fibroblasts were harvested from stock dishes and plated out at 2x105 cells/ml in 6 well plates. A 1cm2 piece of each dressing was cut from the central area and applied either as the dry dressing or a wet dressing following hydration (1ml of cell culture medium). All cut dressings were placed onto the monolayer of fibroblasts and pressed gently in place. After 24 hours the dressings were carefully removed from the surface of the culture, using minimal force to avoid damaging the cells or causing any additional cells to detach from the dressing. The cell numbers on each dressing were determined through trypsinisation and counting using a Neubauer cell counting chamber. Bioadhesion of the Pad Layer of Foam Dressing 90 – 100 Cell Number x1000 Lateral Spread Area x 100 Vial Area Wet Dry 80 Where vial area = original “wound” area = 669.7mm 2 % Lateral Spread 70 60 50 40 30 20 10 New Foam 18.8 ± 5.1 [14.4 – 24.3] 0 Foam A New Foam Foam A 83.6 ± 8.2 [76.9 – 92.8] Foam B 140.0 ± 7.7 [131.3 – 146.0] Lateral Spread (% Area) 140 120 100 % Area Figure 4. Conclusion In-vitro testing shows that the new design of foam cover dressing demonstrates a unique combination of fluid absorption and fluid retention under a force equivalent to 40mmHg (representative of the pressure applied with a high compression bandage) [Table 1], low lateral spread of fluid across the dressing surface [Table 2], intimate contact with a simulated wound bed [Figure 3] and low fibroblast cellular adhesion in a bioadhesion study [Figure 4]. Table 2. 160 Foam B References 80 60 40 20 0 New Foam Foam A Foam B WHRI3524 MS064 In Vitro testing of AQUACEL foam & Competitor Dressings - Intimate Contact.pdf WHRI3525 MS065 In Vitro testing of AQUACEL foam Competitor Dressings - Lateral spread rev 1.pdf WHRI3526 MS066 In Vitro testing of AQUACEL foam Competitor Dressings - Fluid Retention rev 1.pdf CCA084 CVT Trials 17650 & Foam Competitor Products - Evaluation of Cellular Adhesion to Wound Dressings All trademarks are property of their respective owners. Figure 2. © 2012 ConvaTec Inc. AP-012539-MM
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