Randomised controlled trial of excision and grafting with same flap, deffating of skin flap and treatment with steristrips of pre-tibial skin lacerations

ISRCTN	ISRCTN48457322
DOI	https://doi.org/10.1186/ISRCTN48457322
Secondary identifying numbers	N0224149878

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

Dr Graham Gardner
Scientific

South Devon Health Care NHS Trust
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised controlled trial of excision and grafting with same flap, deffating of skin flap and treatment with steristrips of pre-tibial skin lacerations
Study objectives	What is the best treatment option in an A and E setting for cases of pre-tibial lacerations? Three different treatments will be compared to try to establish the better option for patients attending A and E. Healing times will be specifically looked at in each category and pain scores to help improve patient care for the future.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Skin transplantations
Intervention	Excision and grafting with the same flap versus deffating of the skin flap versus put ting steristrips to hold the skin.
Intervention type	Procedure/Surgery
Primary outcome measure	Is there any reduction in mean healing time with any suggested treatments? Any improvement in pain scores?
Secondary outcome measures	Not provided at time of registration
Overall study start date	24/06/2004
Completion date	30/04/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Number of patients to recruit = 200
Key inclusion criteria	Patients attending A and E with pre-tibial lacerations.
Key exclusion criteria	1. Patients who are unable to decide for themselves, patients with dementia, mentally ill 2. Those who cannot understand English/need an interpreter 3. Patients on anticoagulants except aspirin
Date of first enrolment	24/06/2004
Date of final enrolment	30/04/2007

South Devon Health Care NHS Trust

Torquay
TQ2 7AA
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

South Devon Healthcare NHS Trust (UK), NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan