The effect of pre-operative warming on wound infection rates after clean surgery

ISRCTN	ISRCTN54949546
DOI	https://doi.org/10.1186/ISRCTN54949546
Protocol serial number	AP0728
Sponsor	Action Medical Research (UK)
Funder	Action Medical Research (UK)

Submission date: 01/03/2001
Registration date: 01/03/2001
Last edited: 07/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Andrew Melling
Scientific

Professorial Unit of Surgery
North Tees and Hartlepool NHS Trust
North Tees General Hospital
Stockton-on-Tees
TS19 8PE
United Kingdom

Phone	+44 (0)1642 624087
Email	AndyMelling@compuserve.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Laser doppler flowmetry of skin circulation to measure the effects of using two warming therapies: a randomised clinical trial of surgical patients
Study objectives	To assess whether warming patients before short duration, clean surgery will reduce infection rates.
Ethics approval(s)	No ethics approval information required at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Wound infection; masked outcome assessments made at 2 and 6 weeks
Key secondary outcome measure(s)	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
Completion date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	421
Key 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
Key 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
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Professorial Unit of Surgery

Stockton-on-Tees
TS19 8PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/09/2001		Yes	No