Antibiotics, Hysterectomy, Infection Post Op, Prophylactic
Conditions
Keywords
postoperative, infection, hysterectomy, antibiotics
Brief summary
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.
Interventions
DRUGAzithromycin Pill + Cefuroxime
Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
DRUGPlacebo + Cefuroxime
Placebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Sponsors
University of Turku
Tampere University Hospital
Kuopio University Hospital
Oulu University Hospital
Jyväskylä Central Hospital
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
single blinded - the placebo tablets slightly differ from the azithromycin tablets, therefore they are sealed in package which is given straight to the participant
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.
Exclusion criteria
* Inability to understand the study protocol. * Allergy for either cefuroxime or azithromycin. * Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family, * Electrocardiogram will be checked for all the participants. * Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol). * Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of post-hysterectomy episodes with deep infections | Deep infections that occur between the first and 30th postoperative day after hysterectomy | Number of deep wound and pelvic organ infection episodes reported by patients and doctors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of other post-hysterectomy infections or fever episodes | Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy. | Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days |
Countries
Finland
Contacts
Primary ContactPäivi K Rahkola-Soisalo, Adj prof,MD
Backup ContactNinja Savonius, MD
Outcome results
None listed