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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Jyväskylä Central Hospital
RECRUITING
Jyväskylä
Kuopio University Central Hospital
RECRUITING
Kuopio
Oulu University Central Hospital
RECRUITING
Oulu
Tampere University Central Hospital
RECRUITING
Tampere
Turku University Central Hospital
RECRUITING
Turku
Contact Information
Primary
Päivi K Rahkola-Soisalo, Adj prof,MD
paivi.rahkola-soisalo@hus.fi
+358504270411
Backup
Ninja Savonius, MD
ninja.savonius@hus.fi
+358503466986
Time Frame
Start Date: 2022-09-05
Estimated Completion Date: 2030-12
Participants
Target number of participants: 2278
Treatments
Experimental: Azithromycin + Cefuroxime
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.
Active_comparator: Placebo + Cefuroxime
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.
Sponsors
Collaborators: Oulu University Hospital, Tampere University Hospital, University of Turku, Jyväskylä Central Hospital, Kuopio University Hospital
Leads: Helsinki University Central Hospital

This content was sourced from clinicaltrials.gov