A preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds

ISRCTN	ISRCTN60271166
DOI	https://doi.org/10.1186/ISRCTN60271166
Protocol serial number	TGE - W01
Sponsor	TG Eakin Limited (UK)
Funder	Full cost of trial will be funded by TG Eakin Limited (UK)

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

Mr Denis Harkin
Scientific

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

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A preliminary single-centre, randomised, comparative study of the Eakin wound dressing in the management of superficial/partial thickness wounds
Study objectives	Eakin wound dressing is effective and safe for use on humans with superficial/partial thickness wounds.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Eakin wound dressing
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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.
Key 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
Date of first enrolment	01/10/2005
Date of final enrolment	31/01/2006

Royal Group of Hospitals Trust

Belfast
BT12 6BA
United Kingdom

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

07/03/2017: No publications found in PubMed, verifying study status with principal investigator