Disruption or Dehiscence of Closure of Sternum or Sternotomy, Pain, Quality of Life
Conditions
Keywords
pain, comfort, healing, quality of life
Brief 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.
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.
Interventions
DEVICEAdjustable Support Bra
A ClearPoint Medical support bra
Sponsors
Medbuy Pharmacy
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain - Visual Analog Scale | 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 - Pt questionnaire | 6 months after surgery | — |
| Pain - Patient questionnaire | 1 year after surgery | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life pre cardiac surgery - SF12 | Pre-op | Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point. |
| Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale | 6 months | — |
| Comfort - Patient Questionaires | Post-operative period in hospital (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. |
| Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale | 1 year | — |
| Quality of life post cardiac surgery - SF12 | 6 months | — |
| Sternal Wound Dehiscence - Medical Documentation in chart | In hospital post-operative period (approximately 5-7days). | Patients will be tracked during their hospital stay (approximately 5-7days) for sternal wound complications. |
| Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale | Pre-op | Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point. |
Countries
Canada
Contacts
Primary ContactAlison Carre, RN
Backup ContactAlison Carre
Outcome results
None listed