Cardiac Surgical ProceduresDEHISCENCIANCT04290260
Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
A study testing Use of breast bra in people with Cardiac Surgical Procedures and Wound Healing, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiac Surgical Procedures, Wound Healing
- What is being tested?
- Use of breast bra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Nov 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative
- Surgical intervention performed throughout medium sternotomy
Who cannot join
- More than 72 hours admitted in an intensive care unit after surgery
- Cognitive impairment or severe physical disability
- Mastectomy
- External wound occlusion with Opsite® fixative absorbent dressing
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
About this study
Official title: Randomized Controlled Trial of the Effectiveness of Bra Application in Women as a Device for Prevention of Surgical Wound Dehiscence in the Post-operative Cardiac Surgery
The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
Read the detailed description
Background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. There is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound.
Aim: To assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
Methods: Randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. Groups: application of post-surgical or non-surgical breast bra. Endpoint: incidence of dehiscence. Other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. Assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.
- Conditions
- Cardiac Surgical Procedures, Wound Healing
- Being tested
- Use of breast bra, Usual care (not use of bra)
- Keywords
- Cardiovascular nursing, Bra, Dehiscence, Sternotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of breast braOther
Patients will use a breast from admission to hospital discharge
Usual care (not use of bra)Other
| Study group | Role | What they receive |
|---|---|---|
| Use of breast bra | Experimental | Patients allocated on this group wear a breast bra from admission to hospital discharge. Receives: Other: Use of breast bra |
| Usual care | Active comparator | Usual care: participants will not wear a breast bra until discharge from the hospital Receives: Other: Usual care (not use of bra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dehiscence
Dehiscence in the surgical wound. Criteria defined according to an established scale for the assessment of surgical wounds contemplated in the GacelaCare® computer system used in Germans Trias i Pujol University Hospital. Values may be "Yes" or "No".
Measured: Baseline (admission) to 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startJan 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
- Investigators
- Violeta Díaz Herrera, RN, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290260
- Sponsor's protocol ID
- AC-14-060
- Other IDs
- PR-1850/14
- Acronym
- DEHISCENCIA
- Status last verified
- Feb 2020
- First submitted
- 3 Dec 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Effectiveness of Bra Application in Women as a Device for Prevention of Surgical Wound Dehiscence in the Post-operative Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04290260
- Acronym / sponsor ID
- DEHISCENCIA / AC-14-060
- Conditions
- Cardiac Surgical Procedures, Wound Healing
- Keywords
- Cardiovascular nursing, Bra, Dehiscence, Sternotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Feb 2020 (actual)
- 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 aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
Detailed description
Background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. There is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound.
Aim: To assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
Methods: Randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. Groups: application of post-surgical or non-surgical breast bra. Endpoint: incidence of dehiscence. Other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. Assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of breast bra | Experimental | Other: Use of breast braPatients allocated on this group wear a breast bra from admission to hospital discharge. |
| Usual care | Active comparator | Other: Usual care (not use of bra)Usual care: participants will not wear a breast bra until discharge from the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative
- Surgical intervention performed throughout medium sternotomy
Key exclusion criteria (5 listed)
- More than 72 hours admitted in an intensive care unit after surgery
- Cognitive impairment or severe physical disability
- Mastectomy
- External wound occlusion with Opsite® fixative absorbent dressing
- Emergency surgery
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 |
|---|---|---|
| Use of breast braPatients will use a breast from admission to hospital discharge | Other | Use of breast bra |
| Usual care (not use of bra) | Other | Usual care |
Primary outcome
Dehiscence
Time frame: Baseline (admission) to 6 months after hospital discharge
Dehiscence in the surgical wound. Criteria defined according to an established scale for the assessment of surgical wounds contemplated in the GacelaCare® computer system used in Germans Trias i Pujol University Hospital. Values may be "Yes" or "No".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Violeta Díaz Herrera, RN principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of breast bra in people with Cardiac Surgical Procedures and Wound Healing, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2020. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dehiscence (time frame: Baseline (admission) to 6 months after hospital discharge). 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 28 Feb 2020.