Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively 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

Dr Graham Gardner

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes