Condition category
Surgery
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
26/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ucalgary.ca/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes