Condition category
Surgery
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
07/01/2010
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 Andrew Melling

ORCID ID

Contact details

Professorial Unit of Surgery
North Tees and Hartlepool NHS Trust
North Tees General Hospital
Stockton-on-Tees
TS19 8PE
United Kingdom
+44 (0)1642 624087
AndyMelling@compuserve.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP0728

Study information

Scientific title

Laser doppler flowmetry of skin circulation to measure the effects of using two warming therapies: a randomised clinical trial of surgical patients

Acronym

Study hypothesis

To assess whether warming patients before short duration, clean surgery will reduce infection rates.

Ethics approval

No ethics approval information required 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

Infection during surgery

Intervention

Patients were randomised to one of three groups:
1. Standard treatment - no warming
2. Local warming - a minimum of 30 minutes localised warming to the potential incision site using a waming dressing
3. Systemic warming - a minimum of 30 minutes warming to the whole body using a warm blown air blanket

Both warming devices were applied prior to surgery. A cohort of patients had laser doppler and TcPO2 recordings taken prior to warming, after warming and after surgery.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Wound infection; masked outcome assessments made at 2 and 6 weeks

Secondary outcome measures

Added as of 07/01/2010:
1. Skin preparation; masked outcome assessments made at 2 and 6 weeks
2. Length of operation; masked outcome assessments made at 2 and 6 weeks
3. Administration of prophylactic antibiotics; masked outcome assessments made at 2 and 6 weeks
4. Experience of the operating surgeon; masked outcome assessments made at 2 and 6 weeks
5. Core temperature, measured before any treatment, after any warming, and after surgery

Overall trial start date

01/01/2001

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients having clean breast, varicose vein or hernia surgery

Added as of 07/01/2010:
2. Surgery results in a scar longer than 3 cm in length

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

421

Participant exclusion criteria

Added as of 07/01/2010:
1. Under the age of 18 years
2. Pregnant
3. Taking long-term oral steroids
4. Received radiotherapy (to the incision site) or chemotherapy in the last 4 weeks
5. Had an infection at the time of surgery

Recruitment start date

01/01/2001

Recruitment end date

31/12/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professorial Unit of Surgery
Stockton-on-Tees
TS19 8PE
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11567703

Publication citations

  1. Results

    Melling AC, Ali B, Scott EM, Leaper DJ, Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial., Lancet, 2001, 358, 9285, 876-880, doi: 10.1016/S0140-6736(01)06071-8.

Additional files

Editorial Notes