Infections after hysterectomy - a placebo controlled study comparing the profylactic use of azithromycin and cefuroxime with single cefuroxime

Phase 4

Not yet recruiting

• Conditions: Undergoing hysterectomy

• Registration Number: 2024-517508-12-00
• Lead Sponsor: HUS-Yhtymae

Brief Summary

To study post-hysterectomy infections and to compare the use of azithromycin and cefuroxime vs single cefuroxime in antibiotic prophylaxis

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Female
• Target Recruitment: 2278

Inclusion Criteria

Women undergoing hysterectomy for a benign indication in a public hospital in Finland who have not any contraindications for azithromycin or cefuroxime. The person must understand the information given in finnish or swedish.

Exclusion Criteria

Inability to understand the study protocol. Allergy for either cefuroxime or azithromycin. Congenital or acquired prolonged QTc interval. Use of medicines that may prolong QTc interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilidi, amiodarone and sotalol). Use of SSRI medication and prolonged QTc interval.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deep wound and pelvic organ infections up to 30 days postoperatively		Deep wound and pelvic organ infections up to 30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
Surficial infections and other infections, such has urine tract infections, and fever over 38 ℃ over 2 days.		Surficial infections and other infections, such has urine tract infections, and fever over 38 ℃ over 2 days.

Trial Locations

Locations (6)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Keski-Suomen Hyvinvointialue; 🇫🇮 Finland

HUS-Yhtymae; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Kuopio University Hospital

🇫🇮Kuopio, Finland

Henna Kärkkäinen

Site contact

0447172741

henna.karkkainen@kuh.fi