Condition category
Surgery
Date applied
02/12/2004
Date assigned
24/02/2005
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.action.org.uk/research_projects/grant/232/

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 (0)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

Not provided at time of registration

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 measures

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

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

http://www.nth.nhs.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

Publication citations

Additional files

Editorial Notes