A single-centre study of the clinical efficacy of Eakin cohesive paste

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

Ms Marie McGrogan
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Confirmation of the safety and efficacy of Eakin cohesive paste
Key secondary outcome measure(s)	Determination of whether Eakin cohesive paste increases the pouch weartime on high output wounds.
Completion date	01/10/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Royal Group of Hospitals Trust

Belfast
BT12 6BX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Study website	Study website	11/11/2025	11/11/2025	No	Yes