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ISRCTN
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ISRCTN99356681
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ClinicalTrials.gov identifier
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Public title
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A single-centre study of the clinical efficacy of Eakin cohesive paste
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Scientific title
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Acronym
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N/A
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Serial number at source
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TGE/P01
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Study hypothesis
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Eakin cohesive paste is safe for use on patients with high output wounds and stomas.
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Lay summary
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Ethics approval
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Favourable ethical opinion received 16th September 2005.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stoma, ostomy, wound and fistula
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Participants - inclusion criteria
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Patients presenting wounds, stomas and fistulae with greater than 200 ml exudate per day.
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Participants - exclusion criteria
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Patients will be excluded from the study under the following circumstances:
1. Where informed consent is withheld
2. Where the patient is unable to give informed consent due to legal incompetence
3. Where, in the physician's opinion, inclusion in the trial is not advised
4. Where the patient is presenting a critical wound, or is in an emergency situation
5. Where the patient is in the intensive care unit
6. Where there is an open wound in the peristomal region (for stoma patients only)
7. Where the patient is currently participating in another clinical trial
8. Where the patient has a known sensitivity to the product or any of its ingredients
8. Where the patient currently uses stoma paste as part of their regular pouching regime
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Anticipated start date
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01/06/2005
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Anticipated end date
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01/10/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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The trial is a randomised cross over trial. Patients will be assigned a patient identity number and will then be randomly
assigned either to begin with their normal pouching regime or their normal pouching regime and Eakin cohesive paste. At the half way point the treatment will be
switched.
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Primary outcome measure(s)
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Confirmation of the safety and efficacy of Eakin cohesive paste
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Secondary outcome measure(s)
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Determination of whether Eakin cohesive paste increases the pouch weartime on high output wounds.
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Sources of funding
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T G Eakin Limited
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Trial website
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http://www.eakin.co.uk
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Publications
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Contact name
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Ms
Marie
McGrogan
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Address
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Royal Group of Hospitals Trust
Grosvenor Road
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City/town
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Belfast
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Zip/Postcode
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BT12 6BX
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Country
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United Kingdom
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Sponsor
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T G Eakin Limited (UK)
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Address
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15 Ballystockart Road
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City/town
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Comber
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Zip/Postcode
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BT23 5QY
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Country
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United Kingdom
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Sponsor website:
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http://www.eakin.co.uk
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Date applied
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24/01/2005
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Last edited
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14/12/2010
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Date ISRCTN assigned
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16/03/2005
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