Technology update Expert consensus on a new enzyme alginogel
Frequency (%)
Pressure ulcer Diabetic ulcer
Traumatic wounds
Arterial ulcer Other
Total
9 (39.1) 7 (30.4) 3 (13.0)
1 (4.3) 3 (13.0) 23 (100)
Acute (n)
0 3 2
0 3
Chronic (n)
9 4 1
1 0
Median duration (range), days
335 (128–7,128) 246 (22–1,593) 77 (0–397)
1,195 1 0 (0–731) Page Points
1. Based on its composition and modes of action, Flaminal is positioned as an enzyme alginogel.
2. Flaminal is highly conformable and its antimicrobial effect is not accompanied by any cytotoxicity, in contrast to other antimicrobials, such as silver.
Table 2 – Patient demographics in a single-centre, single-arm, open-label case series investigating the efficacy of enzyme alginogels.
structure in terms of fluid uptake. The ‘enzyme alginogel’ classification suggested for Flaminal currently does not fit any existing French category. The requirement to demonstrate reference
to a traditional product has already been fulfilled, in as far as Flaminal has been compared with Intrasite® Gel (Smith & Nephew) [1]
carefully so that light to moderate exudate was managed by Flaminal Hydro and heavier levels by the Forte product — bioburden management is facilitated via the neutrophil- like peroxidase contained in the gel[17]
(Van
Den Plas et al, 2006). Autolytic debridement could be
, which was found to be effective at
reducing wound volume and surface area at seven days. However, larger well-designed randomised
clinical trials are needed with outcome measures including healing rates and wound area regression after four or more weeks of treatment[14,15]
.
MODES OF ACTION Based on its composition and modes of action, Flaminal is positioned as an enzyme alginogel. Enzyme alginogels should be positioned thus in clinical application: Exudate management: there is a standard British Pharmacopaeia test, which has been accepted as a European Standard (European Community, 2011)[16]
. Multiple
samples of Flaminal Forte and Hydro have been subjected to this test in isolation and found to absorb 31.7% and 16.3% of their weight respectively. According to the Standard, this puts them in classes 4 and 2
Bioburden management Autolytic debridement. The concentration of alginate was selected
demonstrated by the effective moisture balance achieved, which is vital to promote optimum healing[18]
. There was a consensus among the panel
brought together for this document that there was limited evidence of autolytic debridement published in clinical reports, despite the positive results achieved without the need for sharp surgical debridement, and that further investigation is needed in this area. Additionally, as clinicians frequently have
to deal with multiple aspects of the TIME framework simultaneously, having a product with a triple mode of action could be cost-effective. Other benefits include its ease of use, particularly in small and hard- to-reach wounds, such as diabetic foot ulcers. Compared with alternative dressings,
such as aliginates in sheet form, Flaminal is highly conformable. Furthermore, its antimicrobial effect is not
accompanied by any cytotoxicity (contrary to experience with other antimicrobials, such as silver). As the antimicrobial effect is not that of a commonplace topical antibiotic, resistance is highly unlikely. The panel stated that further analysis of the effect of Flaminal on wound bacterial
www.woundsinternational.com 49
Technology and product reviews
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57