Actively Recruiting
Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
Led by Helsinki University Central Hospital · Updated on 2024-08-21
2278
Participants Needed
6
Research Sites
429 weeks
Total Duration
On this page
Sponsors
H
Helsinki University Central Hospital
Lead Sponsor
U
University of Turku
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women undergoing hysterectomy for benign reasons at specified University Hospitals
- No contraindications to azithromycin or cefuroxime antibiotics
You will not qualify if you...
- Inability to understand the study protocol
- Allergic to azithromycin or cefuroxime
- Congenital or acquired prolonged QT interval
- History or family history of arrhythmias
- Use of medications that prolong QT interval including class Ia or III antiarrhythmics
- Use of selective serotonin reuptake inhibitors with prolonged QT interval
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Helsinki University Central Hospital
Helsinki, Finland
Actively Recruiting
2
Jyväskylä Central Hospital
Jyväskylä, Finland, 40620
Actively Recruiting
3
Kuopio University Central Hospital
Kuopio, Finland, 70029
Actively Recruiting
4
Oulu University Central Hospital
Oulu, Finland, PL23
Actively Recruiting
5
Tampere University Central Hospital
Tampere, Finland, 33521
Actively Recruiting
6
Turku University Central Hospital
Turku, Finland
Actively Recruiting
Research Team
P
Päivi K Rahkola-Soisalo, Adj prof,MD
CONTACT
N
Ninja Savonius, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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