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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003467-10 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Turku | OTHER |
| Tampere University Hospital | OTHER |
| Kuopio University Hospital | OTHER |
| Oulu University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin + Cefuroxime | Experimental | Changed with renewed study permissions: These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more) in the operating theatre before the incision. The previous description: These patients will receive Azithromycin 500 mg (2 tablets) per orally in the evening before the operation and 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. |
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| Placebo + Cefuroxime | Active Comparator | Changed with new study permissions: These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more)in the operating theatre before the incision. The previous description: These patients will receive placebo (2 tablets) per orally in the evening 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin Pill + Cefuroxime | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of post-hysterectomy episodes with deep infections | Number of deep wound and pelvic organ infection episodes reported by patients and doctors | Deep infections that occur between the first and 30th postoperative day after hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of other post-hysterectomy infections or fever episodes | Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days | Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Päivi K Rahkola-Soisalo, Adj prof,MD | Contact | +358504270411 | paivi.rahkola-soisalo@hus.fi | |
| Ninja Savonius, MD | Contact | +358503466986 | ninja.savonius@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Päivi Rahkola-Soisalo, Adj prof, MD | Helsinki University Central Hospital | Principal Investigator |
| Tomi Mikkola, Prof, MD | Helsinki University Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Recruiting | Helsinki | Finland |
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| OTHER |
| Jyväskylä Central Hospital | OTHER |
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single blinded - the placebo tablets slightly differ from the azithromycin tablets, therefore they are sealed in package which is given straight to the participant
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| Placebo + Cefuroxime | Drug | 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 |
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| Päivi Rahkola-Soisalo, Adj prof, MD |
| Helsinki University Central Hospital |
| Study Director |
| Jyväskylä Central Hospital | Recruiting | Jyväskylä | 40620 | Finland |
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| Kuopio University Central Hospital | Recruiting | Kuopio | 70029 | Finland |
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| Oulu University Central Hospital | Recruiting | Oulu | PL23 | Finland |
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| Tampere University Central Hospital | Recruiting | Tampere | 33521 | Finland |
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| Turku University Central Hospital | Recruiting | Turku | Finland |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D002444 | Cefuroxime |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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