'Cohesive Paste': A Product with Enhanced Comfort and Skin Protection for Stoma Patients
Submitting InstitutionQueen's University Belfast
Unit of AssessmentAllied Health Professions, Dentistry, Nursing and Pharmacy
Summary Impact TypeTechnological
Research Subject Area(s)
Engineering: Biomedical Engineering, Materials Engineering
Summary of the impact
In the UK approximately 100, 000 people have a stoma, an artificial
opening in the bowel that is used to divert the flow of exudate prior to
subsequent external collection. Stoma exudate is a corrosive fluid, which
varies in pH and enzyme content. Therefore, it is important that the stoma
seal adhesive paste operates successfully within a diverse range of
physiological conditions. The novel stoma adhesive developed by Jones and
colleagues through KTP funded research in the School of Pharmacy was
launched by Eakin as Cohesive Paste™ and is now sold in 26
countries, with sales of more than £1M to date.
The design of a stoma adhesive paste that possesses optimal clinical
performance is not trivial. Such systems are required to offer bioadhesion
to and retention at the applied site despite undergoing dilution following
exposure to stoma exudate, a liquid of diverse chemical properties.
Dilution of conventional systems frequently results in a loss of
rheological and hence adhesive properties. Furthermore, the performance of
currently available systems is often compromised by evaporation of the
solvent phase in use, with subsequent detrimental effects on their
rheological properties and retention.
The underpinning research for this project in the School of Pharmacy lay
in the work by Jones (Chair in Biomaterials Science) and colleagues in the
School on bio(muco)adhesion and bioadhesive formulations, and on
biomaterials and medical devices. `Bioadhesion' refers to adhesion to a
biological surface, often a moist surface (sometimes termed
`mucoadhesion'). From 1995-2008, overall grant awards for bioadhesion and
biomaterials research to Jones and colleagues were £1.8M in total, from UK
Research Councils (EPSRC, BBSRC, £469k) and the medical devices/healthcare
industries, with government (£1.3M). An early focus was on developing a
system to deliver antibiotics into the periodontal cavity, where the
challenges were (i) adhesion to a moist epithelial surface and (ii)
retention of the delivery system in the presence of a continuous flow of
aqueous exudate from the periodontal cavity. The research led to a range
of publications1-5 studying the fundamental rheological
behaviour of bioadhesive (mucoadhesive) polymer systems, including their
rheological properties, which were crucial to adhesive performance and
ability to absorb exudate. The work was extended over this period to the
design of moisture-activated bioadhesive platforms (polymeric systems that
only become adhesive following absorption of water) designed as implants
and/or drug delivery systems, the interaction of fluids with biomaterials
and the subsequent effects on the biomaterial system6.
The experience gained from research on periodontal disease and
bioadhesion proved highly relevant to a similar problem of adhesion of
stoma seals (a biomaterial construction) in a moist environment, where a
continuous low-level flow of exudate is also present. Effective adhesion
to a wet surface under these conditions, where the skin/epithelium is
sometimes damaged, is particularly challenging. Conventional adhesives
(e.g. pressure-sensitive adhesives) are unsuitable for damaged skin and
typically fail in a wet environment. If over-wetted (e.g., in situations
where the surface is continually moistened by a flow of aqueous fluid),
bioadhesives can lose adhesion as a slippy mucilage is formed. Thus,
seeking to overcome these challenges, three successive KTP schemes were
established by TG Eakin Ltd, a leading UK manufacturer of stoma products,
with Jones and colleagues in the School of Pharmacy. The schemes, between
1999 and 2007, were worth £377k in research funding and developed the
earlier periodontal adhesive system and related biomaterials research into
a novel stomacare adhesive that provides effective adherence to the
stoma/skin bed in the presence of exudate from the stoma. In so doing,
this system optimised the contact between the stoma bag and the patient,
and decreased the incidence of skin irritation and breakdown.
References to the research
1. JONES, D.S., WOOLFSON, A.D., BROWN, A.F., COULTER, W.A., McCLELLAND,
C. & IRWIN, C.R. 2000. Design, characterisation and preliminary
clinical evaluation of a novel, mucoadhesive topical formulation
containing tetracycline for the treatment of periodontal disease. Journal
of Controlled Release 67 357-368.
2. JONES, D.S., BROWN, A.F., WOOLFSON, A.D., DENNIS, A.C., MATCHETT, L.J.
& BELL, S.E.J. 2000. Examination of the physical state of
chlorhexidine within viscoelastic, bioadhesive semi-solids using Raman
spectroscopy. Journal of Pharmaceutical Sciences 89 (5)
563 - 571.
3. JONES, D.S., BROWN, A.F. & WOOLFSON, A.D. 2001. Rheological
characterisation of bioadhesive, anti-microbial, semi-solids designed for
the treatment of periodontal diseases:
Transient and dynamic viscoelastic and continuous shear analysis. Journal
of Pharmaceutical Sciences 90 (12) 1978 - 1990.
4. JONES, D.S., MULDOON, B.C.O., WOOLFSON, A.D. & SANDERSON, F.D.
2007. An examination of the rheological and mucoadhesive properties of
poly(acrylic acid) organogels designed as platforms for local drug
delivery to the oral cavity. Journal of Pharmaceutical Sciences 96
5. JONES, D.S., WOOLFSON, A.D. & BROWN, A.F. 1998. Viscoelastic
properties of bioadhesive, chlorhexidine-containing semi-solids for
topical application to the oropharynx. Pharmaceutical Research 15
1131 - 1136.
6. ANDREWS, G.P. & JONES, D.S, 2006. Rheological characterization of
bioadhesive binary polymeric systems designed as platforms for drug
delivery implants. Biomacromolecules, 7 899-906.
Grant Awards (KTP Schemes with Eakin Ltd)
(i) 1999-01: £87000 (ii) 2001-03: £139,000 (iii) 2005-07: £151,000
Details of the impact
This case study describes the impact of research on bioadhesion and
biomaterials in the School of Pharmacy, QUB, which resulted in a new
product, Cohesive Paste™, being launched commercially by a leading stoma
care company. Unlike competitors, Cohesive Paste™ offers patients an
alcohol-free, `no sting' formulation particularly suitable for use on
damaged, excoriated skin. Now sold in 26 countries, Cohesive™ was launcheda
commercially in October 2007, with sales building from 2008 onwards to
more than £1M to date. Importantly, the product allowed the company to
provide a complete range of stomacare products (seals, pouches, adhesive
etc.) under the `Cohesive' brand.
Operations for certain bowel conditions, e.g., inflammatory bowel disease
or cancers of the bowel, frequently involve the formation of a stoma, an
artificial opening in the bowel to either temporarily or permanently
divert the flow of faeces (ileostomy or a colostomy). Unfortunately, a
complication associated with stomas is leakage of the bowel contents that,
amongst other issues, e.g., prolapse, hernia, results in high patient
morbidity. The overall incidence of such complications ranges from 21-70%.
Leakage from the stoma is associated with pronounced skin irritation and
breakdown. Cooperative funding from DTI and TG Eakin Ltd (a manufacturer
of stoma products sold worldwide) via a Knowledge Transfer Partnership
(KTP Scheme) led Jones and colleagues in the School of Pharmacy at Queen's
University Belfast to develop a novel bioadhesive product to address the
problems of leakage from the stoma.
Cohesive Pasteb is composed of a hydrophobic
viscoelastic matrix into which a range of hydrophilic bioadhesive polymers
of defined cross-link density and particle size is mechanically dispersed.
Upon contact with exudate, the product, based on the earlier periodontal
and related studies, is designed to control ingress of fluid into the
adhesive, to undergo swelling and to offer enhanced adhesion to the site
of attachment, thereby increasing wear time of the stoma device.
Furthermore, the hydrophilic components form a gel layer that interact
with the components of exudate and prevent these from contacting and
damaging the skin/stoma interface. The design of the novel stoma adhesive
involved complex rheological characterisation of viscoelastic and
bioadhesive properties using the experience and knowledge gained in
earlier underpinning research.
The impact is on the expansion of the company (sales and profitability)
and, importantly, on stoma patients, who benefit from the use of the
product through a decreased incidence of skin irritation and breakdownc.
A nurse testimoniald states that `The Eakin Cohesive
Paste™ also increases the wear time of Eakin Wound Pouches by
adding extra security and protecting the skin from faecal fluid
contamination. This technique works well on both fistula and wound
management. The paste does not break down over prolonged use, expanding
the wear time of wound pouches to 5-7 days. The paste is easily removed
when changing pouches and does not leave a residue on the skin'.
In 2007, the KTP schemee between Eakin and the School
of Pharmacy, which resulted in `Cohesive Paste™', won a KTP Awardf
from the Technology Strategy Board. Indicating the commercial impact, the
company said that they considered the partnership to have been `an
enormous success in developing an entirely new product'. Cohesive Paste™
is now sold in some 26 countries with sales of more than £1M to dateg.
Confirming the beneficial impact on patients and healthcare professionals,
in November 2010 TG Eakin Ltd received the Gold Prizeh
in the `Continence and Stoma Care' category of the `Nursing Times Product
Awards' in London for the `highly innovative Cohesive Paste™'
which, the judges felt, `transformed patient care, helping healthcare
professionals work efficiently'.
Sources to corroborate the impact
(a) Launch of Cohesive Paste
(b) Brochure for Cohesive Paste
(c) Presentation of clinical trial data
(d) Nurse Testimonial on use of Cohesive Paste
e) Confirmation of KTP funding to Jones et al and of the Eakin
Head of KTP and Business Networks, Research and Enterprise Directorate,
Queen's University Belfast
(f) Confirmation of KTP Award to Jones for Cohesive Paste
(g) Marketing Data on Cohesive Paste
International Marketing Executive, TG Eakin Limited
(h) Confirmation of Nursing Times Award for Cohesive Paste