Pectus Excavatum
Conditions
Keywords
Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
Brief summary
The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment
Interventions
DEVICEVacuum Bell
Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* absence of co-morbidities that may interfere with proper placement or function of the apparatus * test negative for pregnancy in women of childbearing age
Exclusion criteria
* skeletal diseases like osteogenesis imperfecta or osteoporosis * clotting disorders such as hemophilia or thrombopathia * skin diseases or infections of the anterior chest wall * angiopathies or vascular fragility * obesity important with BMI greater than 30 * precarious commitment to the prolonged use of the device protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the reduction in the deepness of the pectus excavatum | 3 months | The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of quality of life related to self-esteem | One year | The patients and their parents will be submitted to a quality of life questionnaire in the beginning and after one year using the device |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and adherence to the treatment | three months | The patients will be followed to assure adherence and safety of the treatment |
Countries
Brazil
Outcome results
None listed