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

Completed

• Conditions: Stoma, ostomy, wound and fistula; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN99356681
• Lead Sponsor: T G Eakin Limited (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmation of the safety and efficacy of Eakin cohesive paste

Secondary Outcome Measures

Name	Time	Method
Determination of whether Eakin cohesive paste increases the pouch weartime on high output wounds.