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NCT Number: NCT05337566

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

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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Key information

Conditions

Infection Post Op Antibiotics Hysterectomy Infections Prophylactic

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Number of post-hysterectomy episodes with deep infections

    Time frame: 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 outcomes

  1. Number of other post-hysterectomy infections or fever episodes

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ninja Savonius, MD

CONTACT

[email protected]

+358503466986

Päivi K Rahkola-Soisalo, Adj prof,MD

CONTACT

[email protected]

+358504270411

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Jyväskylä Central Hospital
  • Kuopio University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • University of Turku

Registry information

Official study title

Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime

Important dates

Study start
2022
Primary completion
2025
Study completion
2030
First posted
Apr 20, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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