PainNCT02453945
Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
A study testing Adjustable Support Bra in people with Pain and Disruption or Dehiscence of Closure of Sternum or Sternotomy, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The primary purpose of this study is to examine whether a properly fitted support bra on females improves their quality of life post-sternotomy. Specifically, does a support bra reduce discomfort, pain and wound dehiscence. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Disruption or Dehiscence of Closure of Sternum or Sternotomy, Quality of Life
- What is being tested?
- Adjustable Support Bra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy
Who cannot join
- Patients who have had a previous mastectomy
- Previous radiotherapy to the chest
- Patients who do not read, write or have issues comprehending English
- Patients with cognitive impairments who will not be able to comply with the research study protocol
- Patients requiring physical restraints
- Patients requiring the application of a sternal binder
Trial locations and contacts
1 site in 1 country.
Alison Carre, RN contact
Alison Carre contact
Canada1 site, 1 recruiting
- Recruiting
St Michael
Toronto, Ontario, W3R 5Y6
Alison Carre, RN, 416-864-6060, carrem@smh.ca
Alison Carre, RN, 416-864-6060
About this study
The primary purpose of this study is to examine whether a properly fitted support bra on females improves their quality of life post-sternotomy. Specifically, does a support bra reduce discomfort, pain and wound dehiscence.
Read the detailed description
Participants will be randomized to one arm of the study. One group will be fitted for a support bra and will be asked to wear this bra 24 hours a day for their 6 week post-course. They will submit to 3 questionnaires (at hospital discharge, at 3 weeks post-op and at their 6 week post-op visit with their surgeon. They will diary over this 6 week period re: pain, comfort, wound healing. The group in the no bra arm will also be measured for breast size and will submit to 3 questionnaires (at the same intervals) and will be asked to diary over their 6 week post-op course re: pain, comfort, wound healing. Chronic pain and quality of life markers will be assessed through a 6month and 1 year follow-up telephone call and questionnaire.
- Being tested
- Adjustable Support Bra
- Keywords
- pain, comfort, healing, quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Support BraDevice
A ClearPoint Medical support bra
| Study group | Role | What they receive |
|---|---|---|
| Medical Support Bra | Experimental | ClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days). Receives: Device: Adjustable Support Bra |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Visual Analog Scale
Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Measured: Post-operative period (approximately 5-7days),
Pain - Visual Analog Scale
6-week post-op visit
Measured: 6 weeks
Pain - Pt questionnaire
Measured: 6 months after surgery
Pain - Patient questionnaire
Measured: 1 year after surgery
Secondary outcomes (11)
Comfort - Patient Questionaires
Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Measured: Post-operative period in hospital (approximately 5-7days)
Comfort - Patient Questionaires
Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Measured: 6-week post-op visit
Comfort - Patient Questionaires
Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Measured: 6-months
Comfort - Patient Questionaires
Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Measured: 1-year
Sternal Wound Dehiscence - Medical Documentation in chart
Patients will be tracked during their hospital stay (approximately 5-7days) for sternal wound complications.
Measured: In hospital post-operative period (approximately 5-7days).
Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale
Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point.
Measured: Pre-op
Quality of life pre cardiac surgery - SF12
Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point.
Measured: Pre-op
Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale
Measured: 6 months
Quality of life post cardiac surgery - SF12
Measured: 6 months
Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale
Measured: 1 year
Quality of life post cardiac surgery - SF12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Medbuy Pharmacy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453945
- Sponsor's protocol ID
- R.E.B. number: 15-144
- Status last verified
- Oct 2019
- First submitted
- 19 Feb 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02453945
- Acronym / sponsor ID
- R.E.B. number: 15-144
- Keywords
- pain, comfort, healing, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Medbuy Pharmacy
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to examine whether a properly fitted support bra on females improves their quality of life post-sternotomy. Specifically, does a support bra reduce discomfort, pain and wound dehiscence.
Detailed description
Participants will be randomized to one arm of the study. One group will be fitted for a support bra and will be asked to wear this bra 24 hours a day for their 6 week post-course. They will submit to 3 questionnaires (at hospital discharge, at 3 weeks post-op and at their 6 week post-op visit with their surgeon. They will diary over this 6 week period re: pain, comfort, wound healing. The group in the no bra arm will also be measured for breast size and will submit to 3 questionnaires (at the same intervals) and will be asked to diary over their 6 week post-op course re: pain, comfort, wound healing. Chronic pain and quality of life markers will be assessed through a 6month and 1 year follow-up telephone call and questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Support Bra | Experimental | Device: Adjustable Support BraClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days). |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy
Key exclusion criteria (6 listed)
- Patients who have had a previous mastectomy
- Previous radiotherapy to the chest
- Patients who do not read, write or have issues comprehending English
- Patients with cognitive impairments who will not be able to comply with the research study protocol
- Patients requiring physical restraints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjustable Support BraA ClearPoint Medical support bra | Device | Medical Support Bra |
Primary outcome
Pain - Visual Analog Scale
Time frame: Post-operative period (approximately 5-7days),
Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Pain - Visual Analog Scale
Time frame: 6 weeks
6-week post-op visit
Pain - Pt questionnaire
Time frame: 6 months after surgery
Pain - Patient questionnaire
Time frame: 1 year after surgery
11 secondary outcomes
Comfort - Patient Questionaires
Time frame: Post-operative period in hospital (approximately 5-7days)
Comfort - Patient Questionaires
Time frame: 6-week post-op visit
Comfort - Patient Questionaires
Time frame: 6-months
Comfort - Patient Questionaires
Time frame: 1-year
Sternal Wound Dehiscence - Medical Documentation in chart
Time frame: In hospital post-operative period (approximately 5-7days).
Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale
Time frame: Pre-op
Quality of life pre cardiac surgery - SF12
Time frame: Pre-op
Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale
Time frame: 6 months
Quality of life post cardiac surgery - SF12
Time frame: 6 months
Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale
Time frame: 1 year
Quality of life post cardiac surgery - SF12
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Carre, RN contact
Alison Carre contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Support Bra in people with Pain and Disruption or Dehiscence of Closure of Sternum or Sternotomy, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alison Carre, RN (4168646060), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Visual Analog Scale (time frame: Post-operative period (approximately 5-7days),). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.