Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TGE/P01
Study information
Scientific title
Acronym
Study hypothesis
Eakin cohesive paste is safe for use on patients with high output wounds and stomas.
Ethics approval
Favourable ethical opinion received 16th September 2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Stoma, ostomy, wound and fistula
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Confirmation of the safety and efficacy of Eakin cohesive paste
Secondary outcome measures
Determination of whether Eakin cohesive paste increases the pouch weartime on high output wounds.
Overall trial start date
01/06/2005
Overall trial end date
01/10/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients presenting wounds, stomas and fistulae with greater than 200 ml exudate per day.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/06/2005
Recruitment end date
01/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Group of Hospitals Trust
Belfast
BT12 6BX
United Kingdom
Sponsor information
Organisation
T G Eakin Limited (UK)
Sponsor details
15 Ballystockart Road
Comber
BT23 5QY
United Kingdom
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
T G Eakin Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list