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
Protocol serial number	N0224149878
Sponsor	Department of Health
Funder	South Devon Healthcare NHS Trust (UK), NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Is there any reduction in mean healing time with any suggested treatments? Any improvement in pain scores?
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

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