Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05337566

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing hysterectomy for benign reasons at specified University Hospitals
  • No contraindications to azithromycin or cefuroxime antibiotics
Not Eligible

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

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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

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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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