Contact information
Type
Scientific
Primary contact
Dr Kathryn Margaret King
ORCID ID
Contact details
University of Calgary
Faculty of Nursing
2500 University Drive NW
Calgary
T2N 1N4
Canada
+1 403 220 4643
kingk@ucalgary.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-59756
Study information
Scientific title
Early clinical use of an undergarment (brassiere) in women over a 12 week post-sternotomy recovery period: a randomised controlled trial
Acronym
WREST
Study hypothesis
To test the efficacy of early clinical use of an undergarment (brassiere) in women over a 12 week post-sternotomy recovery period.
Ethics approval
University of Calgary Health Research Ethics Board gave approval on the 20th February 2003.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
First time sternotomy
Intervention
Supplied brassiere (intervention) versus participants' own undergarments (control).
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Pain, discomfort and functional status from post-operative period through 12 weeks of follow-up.
Secondary outcome measures
1. Wound healing and antibiotic use
2. Analgesic and antibiotic use
Overall trial start date
01/05/2003
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women, aged 18 years and older
2. Having cardiac surgery through first-time median sternotomy
3. Informed consent to participate
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
480
Participant 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
Recruitment start date
01/05/2003
Recruitment end date
31/03/2005
Locations
Countries of recruitment
Canada
Trial participating centre
University of Calgary
Calgary
T2N 1N4
Canada
Sponsor information
Organisation
University of Calgary (Canada)
Sponsor details
2500 University Drive N.W.
Calgary
T2N 1N4
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-59756)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2005 study design in http://www.ncbi.nlm.nih.gov/pubmed/15894954
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17161074
Publication citations
-
Study design
King KM, Tsuyuki R, Faris P, Currie G, Maitland A, Collins-Nakai R, The Women's Recovery from Sternotomy (WREST) study: design of a randomized trial of a novel undergarment for early use after sternotomy., Am. Heart J., 2005, 149, 5, 761-767, doi: 10.1016/j.ahj.2004.08.011.
-
Results
King KM, Tsuyuki R, Faris P, Currie G, Maitland A, Collins-Nakai RL, A randomized controlled trial of women's early use of a novel undergarment following sternotomy: the Women's Recovery from Sternotomy Trial (WREST)., Am. Heart J., 2006, 152, 6, 1187-1193, doi: 10.1016/j.ahj.2006.07.026.