Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0224149878
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
24/06/2004
Overall trial end date
30/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients attending A and E with pre-tibial lacerations.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Number of patients to recruit = 200
Participant 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
Recruitment start date
24/06/2004
Recruitment end date
30/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Devon Health Care NHS Trust
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Devon Healthcare NHS Trust (UK), NHS R&D Support Funding
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