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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN99356681 |
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Date of registration:
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16/03/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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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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Date of first enrolment:
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01/06/2005 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN99356681 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Marie
McGrogan |
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Address:
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Royal Group of Hospitals Trust
Grosvenor Road
BT12 6BX
Belfast
United Kingdom |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients presenting wounds, stomas and fistulae with greater than 200 ml exudate per day.
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stoma, ostomy, wound and fistula
Injury, Occupational Diseases, Poisoning
Stoma, ostomy, wound and fistula
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Intervention(s)
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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(s)
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Confirmation of the safety and efficacy of Eakin cohesive paste
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Secondary Outcome(s)
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Determination of whether Eakin cohesive paste increases the pouch weartime on high output wounds.
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Source(s) of Monetary Support
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T G Eakin Limited
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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