Condition category
Skin and Connective Tissue Diseases
Date applied
11/05/2005
Date assigned
15/06/2005
Last edited
15/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Denis Harkin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TGE - W01

Study information

Scientific title

Acronym

Study hypothesis

Eakin wound dressing is effective and safe for use on humans with superficial/partial thickness wounds.

Superficial or partial thickness wounds, including:
Leg ulcers
Diabetic foot ulcers
Pressure ulcers
Other

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Wounds

Intervention

Eakin wound dressing will be trialled against a leading hydrocolloid wound dressing for a period of 5 weeks or until the wound has healed. Dressings will be changed every 4 days.

Intervention type

Drug

Phase

Not Specified

Drug names

Eakin wound dressing

Primary outcome measures

Confirmation of the clinical efficacy and safety of Eakin wound dressing when used in the treatment of superficial/partial thickness wounds. Wound is healed (or reduced in size) over a period of 5 weeks.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

31/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients presenting superficial/partial thickness wounds which could or would normally be treated with a 'hydrocolloid' wound dressing, and who are not precluded by the exclusion criteria below, will be invited to participate in this clinical trial.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 hospital patients

Participant exclusion criteria

Patients will be excluded from the trial under the following circumstances:
1. Wound is >5 cm length or breadth
2. Wound is >0.5 cm depth
3. Wound involving muscle, tendon or bone
4. Wound infection is suspected
5. Where informed consent is withheld
6. Where patients are unable to give informed consent due to legal incompetence, unless informed consent is available from a responsible relative or guardian
7. Where, in the physician's opinion, inclusion in the trial is not advised

Recruitment start date

01/10/2005

Recruitment end date

31/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Group of Hospitals Trust
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

TG Eakin Limited (UK)

Sponsor details

15 Ballystockart Road
Comber
BT23 5QY
United Kingdom

Sponsor type

Industry

Website

http://www.eakin.co.uk/home.asp

Funders

Funder type

Industry

Funder name

Full cost of trial will be funded by TG Eakin Limited (UK)

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