A single-centre study of the clinical efficacy of Eakin cohesive paste
| ISRCTN | ISRCTN99356681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99356681 |
| Secondary identifying numbers | TGE/P01 |
- Submission date
- 24/01/2005
- Registration date
- 16/03/2005
- Last edited
- 04/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Marie McGrogan
Scientific
Scientific
Royal Group of Hospitals Trust
Grosvenor Road
Belfast
BT12 6BX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Eakin cohesive paste is safe for use on patients with high output wounds and stomas. |
| Ethics approval(s) | Favourable ethical opinion received 16th September 2005. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2005 |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Patients presenting wounds, stomas and fistulae with greater than 200 ml exudate per day. |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Royal Group of Hospitals Trust
Belfast
BT12 6BX
United Kingdom
BT12 6BX
United Kingdom
Sponsor information
T G Eakin Limited (UK)
Not defined
Not defined
15 Ballystockart Road
Comber
BT23 5QY
United Kingdom
| Website | http://www.eakin.co.uk |
|---|
Funders
Funder type
Industry
T G Eakin Limited
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
