Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/01/2005
Date assigned
16/03/2005
Last edited
04/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.eakin.co.uk

Contact information

Type

Scientific

Primary contact

Ms Marie McGrogan

ORCID ID

Contact details

Royal Group of Hospitals Trust
Grosvenor Road
Belfast
BT12 6BX
United Kingdom

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 measures

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

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

http://www.eakin.co.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes