A comparison of patient warming versus prophylactic antibiotics on the reduction of wound infection after breast surgery

ISRCTN	ISRCTN63192123
DOI	https://doi.org/10.1186/ISRCTN63192123
Secondary identifying numbers	AP0978

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Leaper
Scientific

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

Phone	+44 1642 624162
Email	profdavidleaper@doctors.org.uk

Study design	Prospective randomised single-blinded controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Patient warming versus prophylactic antibiotics on the reduction of wound infection after breast surgery: a randomised controlled trial
Study objectives	The principle objective is to compare the effect of local warming applied before and after surgery with prophylactic antibiotics on the rate of infection after breast surgery.
Ethics approval(s)	South East Wales Research Ethics Committee
Health condition(s) or problem(s) studied	Breast surgery wound healing
Intervention	Group A: patients receive treatment with a standardised prophylactic antibiotic Group B: patients receive treatment of warming to the chest area using an exothermic warming pad Group C: patients receive both prophylactic antibiotic treatment and patient warming
Intervention type	Procedure/Surgery
Primary outcome measure	The rate of wound infection during the 30-day follow-up period.
Secondary outcome measures	1. Overall wound healing 2. Pain 3. Quality of life
Overall study start date	01/01/2004
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	300
Key inclusion criteria	1. Female patients greater than or equal to 18 years 2. Having clean, non-implant, breast surgery
Key exclusion criteria	1. Under 18 years 2. Pregnant 3. Current infection 4. Fine wire biopsy 5. Implant surgery 6. Diabetic
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2005

North Tees and Hartlepool NHS Trust

Stockton-on-Tees
TS19 8PE
United Kingdom

North Tees and Hartlepool NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Office
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
England
United Kingdom

Website	http://www.nth.nhs.uk/
"ROR"	https://ror.org/04zzrht05

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Intention to publish date	31/12/2011
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Planned publication in a peer reviewed journal
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No

13/06/2017: Publication reference added.