Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
15/02/2012
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

Mr Christopher Walker

ORCID ID

Contact details

Orthopaedic Directorate
RLUH
Prescott Street
Liverpool
L7 8XP
United Kingdom
+44 0151 706 3440
Christopher.Walker@rlbuht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0207182916

Study information

Scientific title

Acronym

Study hypothesis

To study if closure of a surgical wound in the foot or ankle, using a new technique is faster and more comfortable.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Foot and ankle

Intervention

Half of the wounds length will be sutured using the traditional closing technique (control part) and the other half using the traction loop technique. The sutures will be removed in the outpatients department by an experienced nurse clinician. Prior to suture removal a junior nurse will open an envelope to indicate the part of the wound from where the suture removal will start. A junior doctor who will have no participation in the suture removal process will prepare the envelopes. A curtain will be placed, to ensure the patient has no visual contact with the wound during suture removal.

A junior staff nurse or nursing student will be timing suture removal for each part of the wound. Pain during suture removal will be recorded using a 10 point visual analogue scale. Immediately after each part of the wound has been dealt with, patients will be recording their pain, using a specially designed form, without any visual contact between patients and the nurse clinician.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Time and patient discomfort to remove sutures from the surgical wound.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2006

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Sixty eligible adult patients undergoing foot or ankle elective surgery.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2006

Recruitment end date

01/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedic Directorate
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
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

Royal Liverpool and Broadgreen University Hospitals Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12533364

Publication citations

  1. Results

    Gandham SG, Menon D, Prospective randomised trial comparing traditional suture technique with the dynamic sliding loop suture technique in the closure of skin lacerations., Emerg Med J, 2003, 20, 1, 33-36.

Additional files

Editorial Notes