Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof David Leaper
ORCID ID
Contact details
Professorial Unit of Surgery
North Tees and Hartlepool NHS Trust
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom
+44 1642 624162
profdavidleaper@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0978
Study information
Scientific title
Patient warming versus prophylactic antibiotics on the reduction of wound infection after breast surgery: a randomised controlled trial
Acronym
Study hypothesis
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
South East Wales Research Ethics Committee
Study design
Prospective randomised single-blinded controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients greater than or equal to 18 years
2. Having clean, non-implant, breast surgery
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant exclusion criteria
1. Under 18 years
2. Pregnant
3. Current infection
4. Fine wire biopsy
5. Implant surgery
6. Diabetic
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Tees and Hartlepool NHS Trust
Stockton-on-Tees
TS19 8PE
United Kingdom
Sponsor information
Organisation
North Tees and Hartlepool NHS Foundation Trust (UK)
Sponsor details
Research and Development Office
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom
Sponsor type
Government
Website
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 organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal
Intention to publish date
31/12/2011
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in https://www.ncbi.nlm.nih.gov/pubmed/22142317