Infecção do Sítio Cirúrgico
Conditions
Interventions
This is a prospective, randomized, controlled, double-blind, two-arm clinical trial with a total of 106 participants, 53 in the Intervention Group and 53 in the Control Group. Randomization will be pe
s usual practice.
Sponsors
Instituto de Câncer Arnaldo Vieira de Carvalho
Instituto de Câncer Arnaldo Vieira de Carvalho
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 years or older; histopathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, lip, oropharynx, hypopharynx, or larynx; candidates for surgery with curative intent, with or without the need for reconstruction; ability to provide a signed Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Active infection at the time of screening; recent use of antibiotics within the last 14 days prior to surgery; severe immunosuppression defined as chronic use of corticosteroids in immunosuppressive doses, recent myelosuppressive chemotherapy or diagnosis of primary or secondary immunodeficiency such as Human Immunodeficiency Virus (HIV) with CD4 count less than 200 cells per cubic millimeter; previous radiotherapy in the proposed surgical region; need for reoperation at the same surgical site; surgery without curative intent such as palliative surgeries; known allergy to any component of the Prontosan solution such as polyhexanide or betaine; inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the efficacy of the intervention through the incidence of Surgical Site Infection (SSI) verified by means of in-person clinical assessment performed by an independent evaluator blinded to group allocation using the CDC/NHSN diagnostic criteria and the Clavien-Dindo severity classification where the percentage of patients who developed the complication up to the 90th postoperative day will be observed | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the clinical economic and quality of life impact verified through the analysis of medical records and application of questionnaires where we will observe direct costs such as length of hospital and ICU stay in days emergency room visits requirement for reoperations and use of therapeutic antibiotics with record of route and duration in days as well as indirect costs such as duration of enteral nutrition and tracheostomy in days delay in rehabilitation and time away from work in days in addition to clinical outcomes including time to infection onset in days incidence of fistula and flap necrosis healthcare resource utilization for wound care assessment of adverse events by the CTCAE scale quality of life by the EQ-5D-5L questionnaire and pain intensity associated with the use of analgesics measured at multiple time points up to 90 days | — |
Countries
BR
Contacts
Public ContactRafael Souza
Instituto de Câncer Arnaldo Vieira de Carvalho
Outcome results
None listed