Women's recovery from sternotomy (WREST) study

ISRCTN	ISRCTN47669580
DOI	https://doi.org/10.1186/ISRCTN47669580
Protocol serial number	MCT-59756
Sponsor	University of Calgary (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59756)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Kathryn Margaret King
Scientific

University of Calgary
Faculty of Nursing
2500 University Drive NW
Calgary
T2N 1N4
Canada

Phone	+1 403 220 4643
Email	kingk@ucalgary.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Early clinical use of an undergarment (brassiere) in women over a 12 week post-sternotomy recovery period: a randomised controlled trial
Study acronym	WREST
Study objectives	To test the efficacy of early clinical use of an undergarment (brassiere) in women over a 12 week post-sternotomy recovery period.
Ethics approval(s)	University of Calgary Health Research Ethics Board gave approval on the 20th February 2003.
Health condition(s) or problem(s) studied	First time sternotomy
Intervention	Supplied brassiere (intervention) versus participants' own undergarments (control).
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Pain, discomfort and functional status from post-operative period through 12 weeks of follow-up.
Key secondary outcome measure(s)	1. Wound healing and antibiotic use 2. Analgesic and antibiotic use
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	480
Key inclusion criteria	1. Women, aged 18 years and older 2. Having cardiac surgery through first-time median sternotomy 3. Informed consent to participate
Key exclusion criteria	1. Who do not speak and read the English language 2. Present in a clinical preoperative state that suggested a prolonged recovery 3. Do not have telephone access 4. Appear unlikely to complete data collection procedures
Date of first enrolment	01/05/2003
Date of final enrolment	31/03/2005

University of Calgary

Calgary
T2N 1N4
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2006		Yes	No
Other publications	study design	01/05/2005		Yes	No